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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
MEDICINE REGISTRATION OFFICER: CLINICAL POST-REGISTRATION
SALARY: R 738 611.00 – R 937 285.00 per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained post qualification, Internship and Community Service in line with governing frameworks.
Ref No.: SAHPRA 71 of 2025/26
CENTRE: PRETORIA
REQUIREMENTS: Matric Certificate and a four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council) or an MBChB degree and registration as a Medical Officer with the Health Professions Council of South Africa (HPCSA). A relevant Master’s degree in Health Sciences will be an added advantage.
EXPERIENCE:
Grade 1 – A minimum of two (2) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage.
Grade 2 – A minimum of five (5) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and application of good review practices, SAHPRA guidelines, and other relevant international guidelines, e.g., ICH. Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis, and review for safety, efficacy, and quality.
DUTIES: Reviewing a broad range of applications as a primary-, peer reviewer: Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. * Identify key issues and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. * Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules. * Conduct a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. * Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, safety, and adequate directions for product use. * Consult other experts, act as a mentor, and guide assessments to other reviewers by conducting a critical review of their reports. * Ensure timeous reviews of applications.
Conducts evidence-informed practice: Identify the parts of a scientific publication and the general purpose of each part. Search published literature using key terms to find articles on specific subjects related to the application undergoing review. * Summarise the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. * Utilise the full range of reference and resource materials in this area.
Makes or recommends regulatory decisions: Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines, and other relevant international standards for internal peer review and, where necessary, for presentation to the Advisory Clinical Committee. * Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholders.
Technical Validation/Screening of Variation Applications and Responses: Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. * Attend to queries from previous and/or current screening cycle. * Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. * Conduct thorough technical screenings of variation applications for evaluation, i.e., ensuring references submitted to support the proposed amendments are appropriate and complete. * Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. * Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. * Prepare a screening outcome report to be communicated to external stakeholders.
Evaluation of Responses to Variations: Assess submissions for compliance with the Variation addendum and other clinical guidelines. * Primary and peer review of responses with clinical data for simpler molecules. *Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. *Prepare an evaluation outcome (recommendations/queries/approval/non-approval) and communicate the outcome to the applicant.
Audit and Risk Management: Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly PoEs and updating the risk register monthly. * Continuously respond to the needs and expectations of industry, external evaluators, and internal queries within one (1) week. * Adherence to SOPs and SAHPRA, ICH, EMA, and other relevant guidelines. * Develop, review, and improve the accuracy of databases to enable revenue recognition by the Finance Unit. * Respond to relevant queries timeously. * Attend relevant training as and when necessary.
Implement internal communication and provide regulatory support through stakeholder management: Liaising with management, legal, and communication units for advice to clarify established SAHPRA systems and methodologies. * Provides comments, inputs, and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. * Provides regulatory support and guidance to industry and other stakeholders of the Authority. * Provides support to management in the operation of the department/unit. * Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review. * Prepare discussion documents, including agendas, minutes, and action items, and reports where required. * Preparation of recommendations for pharmacovigilance referral outcome. * Capturing and execution of Advisory Clinical Committee recommendations. * Participate in international scientific regulatory forums and discussion groups, including ICH or WHO, as relevant and when nominated. * Provide regular work plans and output to the manager. * Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
MEDICINE REGISTRATION OFFICER: CLINICAL POST-REGISTRATION
SALARY: R 738 611.00 – R 937 285.00 per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained post qualification, Internship and Community Service in line with governing frameworks.
Ref No.: SAHPRA 71 of 2025/26
CENTRE: PRETORIA
REQUIREMENTS: Matric Certificate and a four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council) or an MBChB degree and registration as a Medical Officer with the Health Professions Council of South Africa (HPCSA). A relevant Master’s degree in Health Sciences will be an added advantage.
EXPERIENCE:
Grade 1 – A minimum of two (2) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage.
Grade 2 – A minimum of five (5) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage.
COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and application of good review practices, SAHPRA guidelines, and other relevant international guidelines, e.g., ICH. Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis, and review for safety, efficacy, and quality.
- Computer literacy (MS Office packages) Supervisory skills
- Good planning, organisational, and interpersonal skills
- Good communication skills (written and verbal)
- Innovative thinking, initiative, and leadership qualities
- Dedication and accurate work
- Knowledge of database management will be advantageous
- Must be willing to travel and work irregular hours
- A valid driver’s license
- Ability to work well under pressure
- Collaborative skills
- Knowledge of quality management systems
- Organisational awareness
- Good decision-making and critical analytical skills
DUTIES: Reviewing a broad range of applications as a primary-, peer reviewer: Assess, analyse, and provide recommendations for minor safety amendments (Type Iain and Type IB) applications, including the applicant’s responses to safety concerns raised by either the applicants or the Authority. * Identify key issues and critically evaluate scientific data (i.e., pharmacokinetic, bioavailability, and bioequivalence data, in vitro (pre-clinical) and in vivo clinical studies of a medicine with different endpoints) from multiple sources. * Provide recommendations for major safety and/or efficacy amendments for simpler and complex molecules. * Conduct a comprehensive review to ensure that the risk profile of each medicinal product is regularly updated to incorporate new information and that risk criteria are modified based on new statistical data on hazards, possible damages to manage their impact on clinical practice and public health. * Review and summarise relevant information from clinical trials for product information documents to ensure that the product information contains accurate claims on product effectiveness, safety, and adequate directions for product use. * Consult other experts, act as a mentor, and guide assessments to other reviewers by conducting a critical review of their reports. * Ensure timeous reviews of applications.
Conducts evidence-informed practice: Identify the parts of a scientific publication and the general purpose of each part. Search published literature using key terms to find articles on specific subjects related to the application undergoing review. * Summarise the essential message and purpose of published materials, such as scientific publications, reports, or guidelines. * Utilise the full range of reference and resource materials in this area.
Makes or recommends regulatory decisions: Generate detailed scientific evaluation reports in line with the good review practice guide, ICH guidelines, SAHPRA guidelines, and other relevant international standards for internal peer review and, where necessary, for presentation to the Advisory Clinical Committee. * Prepare evaluation outcome (recommendations/queries/approval/non-approval) to be communicated to the external stakeholders.
Technical Validation/Screening of Variation Applications and Responses: Ensure priority medicines and urgent applications/responses are screened and identified as such for rapid processing as per the priority review policy. * Attend to queries from previous and/or current screening cycle. * Ensure that the outcome is captured on the database and that a rejection/approval letter is sent out to the applicant. * Conduct thorough technical screenings of variation applications for evaluation, i.e., ensuring references submitted to support the proposed amendments are appropriate and complete. * Assess submissions for compliance with the local regulatory requirements as stipulated in the variation addendum and other clinical guidelines. * Direct the implementation of different regulatory pathways based on reliance, collaboration, and recognition. * Prepare a screening outcome report to be communicated to external stakeholders.
Evaluation of Responses to Variations: Assess submissions for compliance with the Variation addendum and other clinical guidelines. * Primary and peer review of responses with clinical data for simpler molecules. *Prepare a critical clinical response evaluation report after the review of the safety and/or efficacy data from clinical studies, published literature sources, reliance decisions of other regulatory authorities, or review of documented signals. *Prepare an evaluation outcome (recommendations/queries/approval/non-approval) and communicate the outcome to the applicant.
Audit and Risk Management: Ensure an unqualified risk and internal audit opinion for Clinical Post-Registrations by submitting monthly PoEs and updating the risk register monthly. * Continuously respond to the needs and expectations of industry, external evaluators, and internal queries within one (1) week. * Adherence to SOPs and SAHPRA, ICH, EMA, and other relevant guidelines. * Develop, review, and improve the accuracy of databases to enable revenue recognition by the Finance Unit. * Respond to relevant queries timeously. * Attend relevant training as and when necessary.
Implement internal communication and provide regulatory support through stakeholder management: Liaising with management, legal, and communication units for advice to clarify established SAHPRA systems and methodologies. * Provides comments, inputs, and advice on international standards and guidance documents, representing the interest of SAHPRA at national, regional, and international levels. * Provides regulatory support and guidance to industry and other stakeholders of the Authority. * Provides support to management in the operation of the department/unit. * Participate in special projects and Pre- and Post-registration working groups as required and engage in technical scientific discussions on ongoing applications under review. * Prepare discussion documents, including agendas, minutes, and action items, and reports where required. * Preparation of recommendations for pharmacovigilance referral outcome. * Capturing and execution of Advisory Clinical Committee recommendations. * Participate in international scientific regulatory forums and discussion groups, including ICH or WHO, as relevant and when nominated. * Provide regular work plans and output to the manager. * Perform any other related duty as requested by the manager/senior manager.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application to be unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
- SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups.
- Applicants with disabilities (should note their disability status) and men are encouraged to apply.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
- For enquiries: Please contact Ms Bafedile Rakgotho, HR Business Partner, via email at bafedile.rakgotho@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 23 February 2026 at 16:00.
MEDICINES REGISTRATION OFFICER: BIOLOGICAL MEDICINES (GRADE 1)
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(CONTRACT POSITION UNTIL 31 MARCH 2028)
SALARY: R738 611.00 per annum (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 70 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: *Applicants must possess a Matric certificate and a relevant four-year Bachelor’s degree in Pharmacy, Biological Sciences, Biochemistry, or Microbiology from a recognized university or tertiary institution at NQF Level 8, as acknowledged by the South African Qualifications Authority (SAQA). Alternatively, an Honours degree in a related health science at NQF Level 8, also recognized by SAQA, is acceptable. For those with a Bachelor of Pharmacy (BPharm) degree, registration with the South African Pharmacy Council (SAPC) is mandatory, and proof of active registration as a Pharmacist must accompany the application. Additionally, having a postgraduate qualification in a relevant scientific field, such as Biochemistry, Vaccinology, or Pharmacology, along with experience in the registration of biological medicines, will be considered an advantage.
EXPERIENCE: * A minimum of three (3) years’ experience within a regulatory environment such as a regulatory pharmacy, production pharmacy, laboratory or within vaccine release environments * Experience in the Biopharmaceutical industry would be advantageous.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines. *Knowledge of the technical aspects for the evaluation of the quality, safety and efficacy of Biological medicines. *Computer literacy and a sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Co-ordination skills. *Written and verbal communication skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills.
DUTIES: ● Evaluation of new applications and peer reviewing of new applications, amendments and responses for biologicals: *Evaluation and assessment of the quality, safety and efficacy of new applications for the registration of Biological Medicines * Evaluation and assessment of applications for the amendment of the quality, safety and efficacy aspects of registered Biological Medicines * Evaluating applicant responses and variations for registrations and/or approval of medicines * Conducting Pre-Registration Consultation meeting for Biological Medicines * Develop and update guidelines and/or SOPs as required * Participate in pre-registration consultations with manufacture *
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
MEDICINES REGISTRATION OFFICER: BIOLOGICAL MEDICINES (GRADE 1)
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(CONTRACT POSITION UNTIL 31 MARCH 2028)
SALARY: R738 611.00 per annum (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 70 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: *Applicants must possess a Matric certificate and a relevant four-year Bachelor’s degree in Pharmacy, Biological Sciences, Biochemistry, or Microbiology from a recognized university or tertiary institution at NQF Level 8, as acknowledged by the South African Qualifications Authority (SAQA). Alternatively, an Honours degree in a related health science at NQF Level 8, also recognized by SAQA, is acceptable. For those with a Bachelor of Pharmacy (BPharm) degree, registration with the South African Pharmacy Council (SAPC) is mandatory, and proof of active registration as a Pharmacist must accompany the application. Additionally, having a postgraduate qualification in a relevant scientific field, such as Biochemistry, Vaccinology, or Pharmacology, along with experience in the registration of biological medicines, will be considered an advantage.
EXPERIENCE: * A minimum of three (3) years’ experience within a regulatory environment such as a regulatory pharmacy, production pharmacy, laboratory or within vaccine release environments * Experience in the Biopharmaceutical industry would be advantageous.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines. *Knowledge of the technical aspects for the evaluation of the quality, safety and efficacy of Biological medicines. *Computer literacy and a sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Co-ordination skills. *Written and verbal communication skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills.
DUTIES: ● Evaluation of new applications and peer reviewing of new applications, amendments and responses for biologicals: *Evaluation and assessment of the quality, safety and efficacy of new applications for the registration of Biological Medicines * Evaluation and assessment of applications for the amendment of the quality, safety and efficacy aspects of registered Biological Medicines * Evaluating applicant responses and variations for registrations and/or approval of medicines * Conducting Pre-Registration Consultation meeting for Biological Medicines * Develop and update guidelines and/or SOPs as required * Participate in pre-registration consultations with manufacture *
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies
- For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 20 February 2026 at 16:00.
VETERINARIAN
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(CONTRACT POSITION UNTIL 31 MARCH 2028)
SALARY: R738 611.00 per annum (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 69 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: ● Applicants must have a Matric certificate and a Bachelor of Veterinary Science degree at NQF Level 8, as recognized by the South African Qualifications Authority (SAQA). Additionally, candidates must be registered in South Africa to practice as a veterinarian. A postgraduate qualification will be considered an advantage.
EXPERIENCE: ● A minimum of three (3) years’ experience in Veterinary clinical practice or in related medicines regulation.
COMPETENCIES, KNOWLEDGE AND SKILLS: ● Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines * Knowledge of the technical aspects for the evaluation of the safety and efficacy of medicines. *Computer literacy and a sound working knowledge of computer software packages * Technical and scientific aspects of medicine regulation * Evaluation of guidelines as prescribed by the relevant regulatory authorities * Planning and organisational skills * Leadership skills * Co-ordination skills. *Written and verbal communication skills * Diversity management * Time management * Good telephone etiquette *.
DUTIES: ● Evaluation of new applications and peer reviewing of new applications, amendments and responses for Veterinary Medicines: * Evaluate and generate evaluation report(s) for registration applications (Generics & New Chemical Entities) in compliance with required template and adopted regulatory /scientific standards (SAHPRA and VICH/EMA technical requirements) and submit for peer review * Evaluate and generate evaluation report(s) for clinical variation applications (Generics & NCEs) in compliance with required template and adopted regulatory/scientific standards (SAHPRA and VICH/EMA guidelines) and submit for peer review. Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates * Peer review primary report(s) compiled by other reviewers * Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters * Prepare query letters to applicants * Prepare a basis of approval or rejection * Provide quality assurance of reports and facilitate resolutions on technical matters. Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review
● Develop and update guidelines, and templates: *Review existing guidelines, and templates and update when necessary * Provide training on guidelines, and templates * Create new guidelines, and templates where relevant *Provide regular work plans and output to the unit manager (qualitative and quantitative reports)
● Form part of technical working groups or special projects and provide support to the unit as well as to advisory committees: *Participate in special projects * Lead and manage assessments, peer review, and discussion working groups, where relevant * Compile discussion documents and reports * Provide regular training to new internal medicine registration officers (MROs) and external evaluators * Take comprehensive notes of discussions of relevant discussions. *Prepare documents for the SAHPRA management/RC meetings.
● Risk Management and Audit: *Adhere to SOPs and guidelines * *Use the most current templates and guidelines * Provide and attend relevant training as may be necessary * Align with Quality Management System requirements * Align with the VICH, WOAH, Codex, and other international standards.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
VETERINARIAN
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(CONTRACT POSITION UNTIL 31 MARCH 2028)
SALARY: R738 611.00 per annum (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 69 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: ● Applicants must have a Matric certificate and a Bachelor of Veterinary Science degree at NQF Level 8, as recognized by the South African Qualifications Authority (SAQA). Additionally, candidates must be registered in South Africa to practice as a veterinarian. A postgraduate qualification will be considered an advantage.
EXPERIENCE: ● A minimum of three (3) years’ experience in Veterinary clinical practice or in related medicines regulation.
COMPETENCIES, KNOWLEDGE AND SKILLS: ● Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines * Knowledge of the technical aspects for the evaluation of the safety and efficacy of medicines. *Computer literacy and a sound working knowledge of computer software packages * Technical and scientific aspects of medicine regulation * Evaluation of guidelines as prescribed by the relevant regulatory authorities * Planning and organisational skills * Leadership skills * Co-ordination skills. *Written and verbal communication skills * Diversity management * Time management * Good telephone etiquette *.
DUTIES: ● Evaluation of new applications and peer reviewing of new applications, amendments and responses for Veterinary Medicines: * Evaluate and generate evaluation report(s) for registration applications (Generics & New Chemical Entities) in compliance with required template and adopted regulatory /scientific standards (SAHPRA and VICH/EMA technical requirements) and submit for peer review * Evaluate and generate evaluation report(s) for clinical variation applications (Generics & NCEs) in compliance with required template and adopted regulatory/scientific standards (SAHPRA and VICH/EMA guidelines) and submit for peer review. Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates * Peer review primary report(s) compiled by other reviewers * Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters * Prepare query letters to applicants * Prepare a basis of approval or rejection * Provide quality assurance of reports and facilitate resolutions on technical matters. Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review
● Develop and update guidelines, and templates: *Review existing guidelines, and templates and update when necessary * Provide training on guidelines, and templates * Create new guidelines, and templates where relevant *Provide regular work plans and output to the unit manager (qualitative and quantitative reports)
● Form part of technical working groups or special projects and provide support to the unit as well as to advisory committees: *Participate in special projects * Lead and manage assessments, peer review, and discussion working groups, where relevant * Compile discussion documents and reports * Provide regular training to new internal medicine registration officers (MROs) and external evaluators * Take comprehensive notes of discussions of relevant discussions. *Prepare documents for the SAHPRA management/RC meetings.
● Risk Management and Audit: *Adhere to SOPs and guidelines * *Use the most current templates and guidelines * Provide and attend relevant training as may be necessary * Align with Quality Management System requirements * Align with the VICH, WOAH, Codex, and other international standards.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
- SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups.
- Applicants with disabilities (should note their disability status) and men are encouraged to apply.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies
- For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 20 February 2026 at 16:00.
MEDICINES REGISTRATION OFFICER: BIOLOGICAL MEDICINES (LOT RELEASE) (GRADE 2)
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(3 YEAR CONTRACT POSITION)
SALARY: R883 088.00 per annum (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 68 OF 2025/26
CENTRE: Pretoria
REQUIREMENTS: Applicants must possess a Matric certificate and a relevant four-year Bachelor of Pharmacy, Biological Sciences, Biochemistry or Microbiology degree from a recognised university or tertiary institution at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) or an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA * (Registration with the South African Pharmacy Council (SAPC) is a requirement with a BPharm degree - proof of active registration as a Pharmacist application) * A postgraduate qualification in relevant Science such as Biochemistry, Vaccinology, Pharmacology or equivalent and experience in biological medicines registration is an added advantage.
EXPERIENCE: ● A minimum of five (5) years’ experience within a pharmaceutical environment or related medicines regulation, medicine production quality assurance, in biological medicines registration or within vaccine release environments * Experience in the Biopharmaceutical industry would be advantageous.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines * Knowledge of the technical aspects for the evaluation of the quality, safety and efficacy of biological medicines * Ability to meet tight deadlines and manage multiple, often competing priorities * Computer literacy and a sound working knowledge of computer software packages * Technical and scientific aspects of medicine regulation * Evaluation guidelines as prescribed by the relevant regulatory authorities * Planning and organisational skills * Leadership skills * Co-ordination skills * Written and verbal communication skills * Diversity management * Time management * Good telephone etiquette * Supervisory skills.
DUTIES: ● Evaluation of new applications and peer reviewing of new applications, amendments and responses for biologicals: *Evaluation and assessment of the quality, safety and efficacy of new applications for the registration Biological Medicines * Evaluation and assessment of applications for the amendment of the quality, safety and efficacy aspects of registered Biological Medicines * Evaluating applicant responses and variations for registrations and/or approval of Biological medicines * Conducting Pre-Registration Consultation meeting for Biological Medicines * Develop and update guidelines and/or SOPs as required * Participate in pre-registration consultations with manufacture * Ensure continued compliance with QSE and regulatory standards *Lot release functions for Vaccines.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies
- For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 20 February 2026 at 16:00.
SENIOR MANAGER: MEDICAL DEVICES AND RADIATION CONTROL
SALARY LEVEL 14: R1 565 650 – R1 661 741 (A TOTAL COST TO COMPANY PACKAGE)
REF NO.: SAHPRA 67/2025 (5-YEAR CONTRACT)
CENTRE: PRETORIA
REQUIREMENTS: A Matric certificate and an appropriate Master’s degree in Biomedical Engineering, Clinical Engineering, Medical Physics, or a related equivalent qualification at NQF Level 9, as recognised by the South African Qualifications Authority (SAQA). A management qualification such as a Master of Business Administration (MBA), Master of Business Leadership (MBL), or a Management Advancement Programme (MAP) will be an added advantage. A valid driver’s licence is required, as the position involves travel.
MANDATORY EXPERIENCE A minimum of ten (10) years’ relevant experience in the medical devices and/or radiation control regulatory environment, of which at least five (5) years must be at a management level (Levels 12–13) supporting business operations. Experience of two (2) years at a senior management level (Levels 13–14) will be an added advantage. Extensive knowledge and practical application of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), and its Regulations; the Hazardous Substances Act, 1973; and the National Health Act, 2003 are required. Proven experience in project management and stakeholder management is essential.
REQUIRED KNOWLEDGE SKILLS, ABILITIES, AND COMPETENCIES: *Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. *Sound and in- depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act and the Hazardous Substances Act, 1973 and its regulations. *Sound knowledge of regulatory scientific and technical requirement (to assess the quality, safety and efficacy and or performance aspect). *Sound and in-depth knowledge of the administrative processes for regulation of the medical devices, radionuclides and electronic generation of ionizing and non-ionizing radiation in the Republic of South Africa. *Good understanding of the medical device and radiation industry. *Detailed knowledge of various international standards and norms *Knowledge of complaint management system. *A track record in preparation and management of strategic plans, annual performance and operational plans *Knowledge of budgeting and financial management system. *Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of 1999) (PFMA), Labour Relations Act, 1966 (Act 66 of 1995) and the Employment Equity Act, 1998 (Act 55 of 1998). *General management including Human Resources, budgeting and financial management skills. *Good planning, organisational and presentation skills. *Performance measurement skills, *Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills. *Research and investigation, Analytical and report writing skills; Computer skills. *Resilience and ethical behaviour. *Must be willing to travel and work irregular hours. *A valid driver’s licence. Experience in and knowledge of health products regulation. A good understanding of the pharmaceutical, complementary medicines and medical device industries. Familiarity with international best practices in health product regulation and understanding of how these would relate to the South African context. Excellent awareness of South Africa’s health policy. In-depth understanding and knowledge of all relevant legislation, including the Medicines and Related Substances Act and the Public Finance Management Act (PFMA). Proven track record in the development and implementation of technical and operational strategies.
DUTIES: Strategic and Operational Leadership: Develop strategy, annual performance plan, operational plans, and budget for the Medical Device and Radiation Control Programme, aligned with organisational needs and optimal resource utilisation. Contribute as a member of the senior management team responsible for strategic and operational planning of the organisation in order to ensure the achievement of organisational objectives and meet the needs of all stakeholders. Develop and coordinate systems for managing all programme operations.
Regulatory Oversight and Compliance: Direct regulation of medical devices (including medical and industrial radiation-emitting devices), radionuclides, and electronic generation of ionizing and non-ionizing radiation. Oversee preparation and endorsement of reports to technical and advisory committees per legal requirements and SAHPRA standard operating procedures (SOPs). Oversee development, implementation, and maintenance of regulations, guidelines, policies, and procedures aligned with international/national protocols and legislation. Ensure accurate, timely statutory reporting; full adherence to SAHPRA policies, SOPs, Terms of Reference (ToRs), and manuals; and performance management against standards, identifying improvement opportunities. Establish surveillance mechanisms to detect, assess, and prevent adverse reactions to devices, radionuclides, and radiation sources. Oversee compliance with service level agreements for outsourced services (e.g., laboratories) to meet quality and delivery standards.
Reporting and Communication: Prepare monthly, quarterly, and annual reports on programme work, including timeline monitoring. Oversee effective, timeous communication and consultation on issues related to medical devices, radiation-emitting devices, radionuclides, and radiation generation. Share critical updates (e.g., strategy/legislative changes).
Stakeholder and International Engagement: Liaise with both local and international regulators and stakeholders to ensure accurate information exchange and productive relationships. Ensure active South African regulatory authority participation in the global arena. Build sustainable partnerships with public and private sectors to deliver SAHPRA programmes.
Financial, People, and General Management: Oversee programme budget, implement cost-saving measures in line with PFMA and Treasury regulations, and handle general financial responsibilities. Lead, train, and develop the team to meet performance targets, boost efficiency, and align with organisational needs. Foster ethical conduct, integrity, and superior performance standards across the team. Undertake any additional duties assigned by the Chief Regulatory Officer or Chief Executive Officer.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
SENIOR MANAGER: MEDICAL DEVICES AND RADIATION CONTROL
SALARY LEVEL 14: R1 565 650 – R1 661 741 (A TOTAL COST TO COMPANY PACKAGE)
REF NO.: SAHPRA 67/2025 (5-YEAR CONTRACT)
CENTRE: PRETORIA
REQUIREMENTS: A Matric certificate and an appropriate Master’s degree in Biomedical Engineering, Clinical Engineering, Medical Physics, or a related equivalent qualification at NQF Level 9, as recognised by the South African Qualifications Authority (SAQA). A management qualification such as a Master of Business Administration (MBA), Master of Business Leadership (MBL), or a Management Advancement Programme (MAP) will be an added advantage. A valid driver’s licence is required, as the position involves travel.
MANDATORY EXPERIENCE A minimum of ten (10) years’ relevant experience in the medical devices and/or radiation control regulatory environment, of which at least five (5) years must be at a management level (Levels 12–13) supporting business operations. Experience of two (2) years at a senior management level (Levels 13–14) will be an added advantage. Extensive knowledge and practical application of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), and its Regulations; the Hazardous Substances Act, 1973; and the National Health Act, 2003 are required. Proven experience in project management and stakeholder management is essential.
REQUIRED KNOWLEDGE SKILLS, ABILITIES, AND COMPETENCIES: *Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. *Sound and in- depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act and the Hazardous Substances Act, 1973 and its regulations. *Sound knowledge of regulatory scientific and technical requirement (to assess the quality, safety and efficacy and or performance aspect). *Sound and in-depth knowledge of the administrative processes for regulation of the medical devices, radionuclides and electronic generation of ionizing and non-ionizing radiation in the Republic of South Africa. *Good understanding of the medical device and radiation industry. *Detailed knowledge of various international standards and norms *Knowledge of complaint management system. *A track record in preparation and management of strategic plans, annual performance and operational plans *Knowledge of budgeting and financial management system. *Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of 1999) (PFMA), Labour Relations Act, 1966 (Act 66 of 1995) and the Employment Equity Act, 1998 (Act 55 of 1998). *General management including Human Resources, budgeting and financial management skills. *Good planning, organisational and presentation skills. *Performance measurement skills, *Excellent Communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills. *Research and investigation, Analytical and report writing skills; Computer skills. *Resilience and ethical behaviour. *Must be willing to travel and work irregular hours. *A valid driver’s licence. Experience in and knowledge of health products regulation. A good understanding of the pharmaceutical, complementary medicines and medical device industries. Familiarity with international best practices in health product regulation and understanding of how these would relate to the South African context. Excellent awareness of South Africa’s health policy. In-depth understanding and knowledge of all relevant legislation, including the Medicines and Related Substances Act and the Public Finance Management Act (PFMA). Proven track record in the development and implementation of technical and operational strategies.
DUTIES: Strategic and Operational Leadership: Develop strategy, annual performance plan, operational plans, and budget for the Medical Device and Radiation Control Programme, aligned with organisational needs and optimal resource utilisation. Contribute as a member of the senior management team responsible for strategic and operational planning of the organisation in order to ensure the achievement of organisational objectives and meet the needs of all stakeholders. Develop and coordinate systems for managing all programme operations.
Regulatory Oversight and Compliance: Direct regulation of medical devices (including medical and industrial radiation-emitting devices), radionuclides, and electronic generation of ionizing and non-ionizing radiation. Oversee preparation and endorsement of reports to technical and advisory committees per legal requirements and SAHPRA standard operating procedures (SOPs). Oversee development, implementation, and maintenance of regulations, guidelines, policies, and procedures aligned with international/national protocols and legislation. Ensure accurate, timely statutory reporting; full adherence to SAHPRA policies, SOPs, Terms of Reference (ToRs), and manuals; and performance management against standards, identifying improvement opportunities. Establish surveillance mechanisms to detect, assess, and prevent adverse reactions to devices, radionuclides, and radiation sources. Oversee compliance with service level agreements for outsourced services (e.g., laboratories) to meet quality and delivery standards.
Reporting and Communication: Prepare monthly, quarterly, and annual reports on programme work, including timeline monitoring. Oversee effective, timeous communication and consultation on issues related to medical devices, radiation-emitting devices, radionuclides, and radiation generation. Share critical updates (e.g., strategy/legislative changes).
Stakeholder and International Engagement: Liaise with both local and international regulators and stakeholders to ensure accurate information exchange and productive relationships. Ensure active South African regulatory authority participation in the global arena. Build sustainable partnerships with public and private sectors to deliver SAHPRA programmes.
Financial, People, and General Management: Oversee programme budget, implement cost-saving measures in line with PFMA and Treasury regulations, and handle general financial responsibilities. Lead, train, and develop the team to meet performance targets, boost efficiency, and align with organisational needs. Foster ethical conduct, integrity, and superior performance standards across the team. Undertake any additional duties assigned by the Chief Regulatory Officer or Chief Executive Officer.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
- SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups.
- Applicants with disabilities (should note their disability status) and men are encouraged to apply.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
- For enquiries: Please contact Mr Tshepo Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 20 February 2026
MANAGER: BIOLOGICAL MEDICINES
(PHARMACEUTICAL EVALUATION MANAGEMENT)
SALARY: LEVEL 12 (R 1 108 280 – R 1 176 293) per annum (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 39 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: ● Matric certificate and appropriate four-year Bachelor’s degree in Pharmacy, Biological Sciences, Biochemistry, or Microbiology from a recognised university or tertiary institution at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), or an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA. Registration with the South African Pharmacy Council (SAPC) is required for applicants with a BPharm degree. Proof of active registration as a Pharmacist must accompany the application. A postgraduate qualification in a relevant science such as Biochemistry, Vaccinology, Pharmacology, or equivalent, and experience in biological medicines registration will be an added advantage. A valid driver’s licence is required.
EXPERIENCE ● A minimum of ten (10) years relevant experience in medicines regulatory field in evaluating/compiling safety, quality and efficacy data for biological medicines, including product information and patient information leaflets. At least five (5) years must be with Biotherapeutics at a supervisory/management level (Level 09 – 12) supporting business operations * Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations * Knowledge of database management is required.
COMPETENCIES, KNOWLEDGE, AND SKILLS: * Knowledge of and experience with relevant national legislation, international standards, and best practices, e.g., IMDRF, WHO, AMDF, GHWP * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions * Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines * Knowledge of technical aspects for the evaluation of quality, safety, and efficacy of medicines * Leadership skills * Preparation and management of strategic plans, business plans, and budgeting * Performance measurement skills * Diversity management * Time management * Technical and scientific aspects of medicine regulation * Self-motivated and able to work independently * Computer literacy and a sound working knowledge of computer software packages * Ability to manage a variety of cross-functional team members * Competent in problem-solving and team building * Information evaluation * Decision making * Objectivity. * Resilience * Communication skills (verbal, written, negotiation, conflict management, presentation) * Ethical behaviour * Planning and organising skills * Interpersonal skills * Assertiveness.
DUTIES:
Provide regulatory strategic direction and management of activities of the Biological Medicines Unit, including risk management and audit.
- Manage the operations of the Biological Medicines Unit concerning the processes, inputs, targets, outputs, and resourcing requirements to ensure effective operation within the unit.
- Manage the development of regulations, regulatory processes, and guidelines within the Biological Medicines Unit to ensure efficiency, considering best practice and guidelines.
- Perform quality assurance of processes and outputs to ensure compliance with legislative and regulatory requirements.
- Planning and coordination of the work of staff members.
- Interpret the organisational strategy and develop a comprehensive operational strategy for the business unit that aligns with organisational goals and objectives.
- Contribute to development Implementation of the Annual Performance Plan (APP) targets for the unit as per the approved strategic plan.
- Continuous monitoring and effective compliance implementation of the unit-specific APP as per the approved plan.
- Compilation of statistics of the Unit to compile reports for monthly, quarterly, and annual presentations.
- Supervision of the technical and administrative work of the Unit.
- Supervision of assessment and authorisation of registered and new registration applications of Biological Medicines.
- Support the work of the technical advisory committee
Supporting the work of the SAHPRA and its Advisory Committees:
- Providing administrative and technical support to SAHPRA on the registration and amendments of biological meetings.
- Implementation of experts and SAHPRA resolutions.
- Overseeing the recording of committee recommendations and technical discussions.
- Overseeing document preparation for expert meetings.
Management of evaluation and assessment of registration and amendments of biological medicines:
- Peer reviewing/evaluation and assessment of applications for the amendment of the quality and clinical aspects of registered biological medicines.
- Assessment and evaluation of applications for the registration of biological medicines (new active agents and follow-ons).
- Peer reviewing/evaluation of quality and clinical aspects of applicant responses to committee recommendations.
- Screening and allocation of applications to internal and external technical reviewers.
- Making reference to other international guidelines from countries, SAHPRA aligns itself with EMEA, FDA, TGA, and others, including WHO.
- Research on regulatory sciences and medicinal development registration.
Development/Update of technical guidelines and maintenance of policy, managing risk and audit queries:
- Development of SOPs, regulations, and guidelines for registration of biological medicines and their updating.
- Drafting of policy documents and maintenance of policy and ensuring compliance by the applicants.
- Ensure that SAHPRA attains and maintains global best practice.
Conduct consultation meetings:
- Conduct consultation meetings with representatives from the biological medicines industry to advise on administrative and technical issues.
- Handling/responding to enquiries and complaints from clients.
- Responsiveness to external inquiries by industry and other departments in SAHPRA and other external stakeholders.
- Industry engagements, other regulatory forums regionally and internationally.
Lot Release of Vaccines:
- Overseeing of vaccines and biological medicines’ Lot Release.
- Chair or facilitate the monthly meeting.
- Initiate any engagement with SANCL informed by regulatory needs and requirements for vaccines.
- Confirms and compiles the received Lot Release documents for further handling by the finance department.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
- SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups.
- Applicants with disabilities (should note their disability status) and men are encouraged to apply.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies
- For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
- The closing date is 20 February 2026 at 16:00.
MEDICINES CONTROL OFFICER: REGULATORY COMPLIANCE
(FIXED TERM CONTRACT: UNTIL 30 MARCH 2028)
SALARY: R738 611.00 – R937 285.00 PER ANNUM (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained post-qualification and community service in line with governing frameworks
Ref No.: SAHPRA 66/2025
CENTRE: Pretoria
REQUIREMENTS:
Matric certificate and a four-year Bachelor of Pharmacy degree. Registration as a Pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA). A relevant Master’s qualification at NQF Level 9, as recognised by SAQA, will be an added advantage. Valid driver’s licence.
EXPERIENCE
Grade 1: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist with the SAPC at NQF level 8 as recognised by SAQA plus a minimum of three (3) years’ experience as a practising pharmacist post community service, of which two (2) should be in pharmaceutical regulatory environment.
Grade 2: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist the SAPC at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience as a practising pharmacist post community service, of which three (3) should be in pharmaceutical regulatory environment.
COMPETENCIES, KNOWLEDGE AND SKILLS
*A solid understanding of application procedures. *Medicines Act as Amended and its Regulations. *Consolidated Schedules. *Planning and organisational skills. *Interpersonal skills. *Investigation skills. *Computer skills and knowledge of MS Office. *Drive and self-management skills. *Communication skills. *Report writing. *Resilience. *Assertiveness. *Ethical behaviour. *Ability to work under pressure and irregular hours. *Professionalism. *Ethical conduct and adherence to the SAHPRA Code of Conduct. *Integrity. *Presentation *Problem-solving *Decision making *Report writing *Interpersonal *Agility and *Resilience *Self-management skills* Analytical
DUTIES:
Operational Management
Ensure compliance with the provisions of the Medicine and Related Substances Act 101 of 1965 as amended, through the implementation of the strategies for preventing, detecting and responding to Substandard, Falsified, unregistered, unauthorized health products in the market.
Key activities for this function include actively monitoring compliance with health products.
*Import & export, Advertisements, marketing and promotions, Raid alerts and recalls, Seizures & destructions, *Requiring approval Sections 36 exclusions. *Requiring approval for Donations. *Post-Market Surveillance Sampling and Testing throughout supply chain. *Investigations of non-compliance. *Joint operations/raids with enforcement agencies. *At border posts not designated for health products and conducts training. *By attending court/s as required and any matters related to courts. *Through Strengthening Cooperation and collaboration with stakeholders locally and internationally (e.g. training, meetings, conference, information sharing and joint operations). *Through providing Administrative & Technical Support. *Classified as Narcotics and Psychotropics substances. *Conducting routine and pro-active surveillance inspections at applicable facilities and those allocated. *Implementation of the National Action Plan against Substandard, Falsified medical products (SFs). *Involves extensive and continuous travel.
Governance, Compliance + Risk
*Achieve and maintain process quality. *Adherence with the OHSA to ensure a safe + healthy working environment. *Ensure adherence to all process quality assurance requirements. *Compile SOPs, Review SOP and Guidelines as per QMS requirements. *Assist with Performance Reporting within the predetermined timeline. *Identify and record operational risks and consult with the Unit Manager. *Mitigate risks within operational control. *Resolve the operational risks effectively and timeously. *Filing of evaluation reports under respective product folders. *Assisting with the compliance of the Quality Management System requirements of the unit. *Identify and record operational risks and consult with Unit Manager
People Management
*Self-management. *Manage own Performance and Individual Development Plan. *Support other colleague inspectors. *Support admin screener Performance and Border Medicines Control Technicians activities. *Team leadership in peer review meetings, inspection, raid or training assigned to you. *Maintain good relations within the SAHPRA environment. *Living the SAHPRA values. *Sharing knowledge + informal coaching other peers (as applicable)
Financial Management
*Participate in cost saving initiatives. *Populate relevant folders and trackers for Finance Reporting within predetermined timeframe. *Collating, compiling, and submitting accurate reports in a timely manner to satisfy statutory and business requirements as well as the able to communicate key financial messages to stakeholders with clarity and consistency. *Provide general advice on all related financial matters to all relevant colleagues involved, directly or indirectly, in the financial circuit. *Monitors and maintains all required financial records for compliance and audit to all agreed requirements. *Collate financial data and reports for analysis and to facilitate decision making.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
Incomplete applications or applications without the aforementioned documents or information will not be considered.
No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
Applicants should note that pre-suitability checks will be conducted after they have been shortlisted.
Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups.
Applicants with disabilities (should note their disability status) and men are encouraged to apply.
SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013.
CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
For enquiries: Please contact Mr I Mosenyi, HR Business Partner, via email at itumeleng.mosenyi@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
The closing date is 19 February 2026 at 16:00.
INSPECTOR GOOD MANUFACTURING PRACTICES (GMP)
SALARY: R935 152.00 – R992 542.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 65 of 2025/26
CENTRE: Pretoria
REQUIREMENTS: ● Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or Honours Degree in Chemistry or equivalent Health Science related qualification NQF level 8 as recognised by the South African Qualifications Authority (SAQA).
EXPERIENCE: Minimum of three (3) years’ experience in the pharmaceutical industry or GMP environment. Experience must be post-community service. Knowledge of GMP regulations and industry practice, as well as experience in undertaking GMP inspections within a regulatory environment. Registration as a Pharmacist with the South African Pharmacy Council or the relevant regulatory body, if applicable. Valid Driver’s License
COMPETENCIES, KNOWLEDGE AND SKILLS: * Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *Ability to make effective decisions by using evidence and knowledge to support accurate, expert decisions and advice while carefully considering the implications of such a decision. *Ability to work unsupervised for long periods of time. * Ability to work within a team environment. *Ability to meet tight deadlines and manage multiple, often competing priorities. * Excellent interpersonal & communication skills (written & verbal). *Critical thinking. *Ability to exercise good judgment and solve problems quickly and effectively. *Computer skills. *Solution orientated. *Work under pressure. *Ability to maintain high levels of confidentiality. *Interpersonal + Intrapersonal Skills. *Accuracy + Attention to detail. *Time Management Skills. *Planning and organising skills. *Professionalism. *Honesty + Integrity. *Innovative. *Patience + empathy. *Courageous decision-making. *Conceptual reasoning. *Systemic thinking. *People Management + Empowerment. *Change Management. *Knowledge Management. *Service Delivery innovation. *Problem Solving + Analysis. *Client Orientation + Customer focus. *Proactive Stakeholder Management. *Situational adaptability.
DUTIES: Operational Management: *Inspect different disciplines of pharmaceutical manufacturing, importing or exporting sites such as import/export/applicant and non-sterile manufacturing for compliance with Good Manufacturing Practices as accepted by SAHPRA. * Inspect non-sterile pharmaceutical testing laboratories (chemical and microbiological) for compliance with Good Manufacturing Practices as accepted by SAHPRA. * Planning of GMP inspections as per the inspection plan and travel arrangements for local, national and international inspections. * To work closely across inspection teams, SAHPRA programmes and external regulators to ensure inspection activities are planned and communicated effectively. * To adhere to the SAPRHA QMS processes * To report instances of suspected or known non-compliance and ensure it’s handled in the appropriate manner. * Prepare reports for SAHPRA and relevant advisory committees and the Finance department. * Liaise with inspectors from international regulatory authorities.* To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. * Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes. * Conduct GMP inspections in line with the requirements of the Medicine and Related Substances Act, No. 101 of 1965. * Report writing. * Response review. * Summary and recommendation writing.
Financial Management:
Participate in cost saving initiatives.
Governance, Compliance + Risk:
*Achieve and maintain process quality. * Adherence with the OHSA to ensure a safe + healthy working environment. * Ensure adherence to all process quality assurance requirements. * Inspections cost effective and productive planning and execution. * Follow up on inspection reports within the specified time frame. * Management of office and inspection equipment e.g. car, EPD's, survey meter, TEAMS line, Data and laptop. * Participate in development of SOP, process flow charts, documents, templates etc. * Perform office administrative tasks and handling of queries.
People Management:
*Self-management. * Manage own Performance Management and Individual Development Plan.
* Living the SAHPRA values. * Drive collaborative leadership.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
Interested candidates who meet the above requirements should submit an application clearly indicating the title of the position and reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources
Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
Incomplete applications or applications without the aforementioned documents or information will not be considered.
No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
Due to the larger number of responses anticipated, communication will be limited to the short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996) and the Employment Equity Act, 55 of 1998.
SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups. Applicants with disabilities are encouraged to apply and indicate their disability status.
SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013.
CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
For enquiries: Please contact Mr I Mosenyi, HR Business Partner, via email at itumeleng.mosenyi@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
The closing date is 17 February 2026 at 16:00.