SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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RECRUITMENT OF INDEPENDENT RISK, AUDIT AND GOVERNANCE COMMITTEE (“RAG”) MEMBER OF THE SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (“SAHPRA”) 
APPLICATIONS ARE INVITED FROM SUITABLY QUALIFIED AND EXPERIENCED CANDIDATES TO SERVE AS A MEMBER OF THE SAHPRA, RISK, AUDIT AND GOVERNANCE COMMITTEE (“RAG”). 
REMUNERATION: IN ACCORDANCE WITH NATIONAL TREASURY RATES 
REFERENCE NO.: SAHPRA 10/2025 
CENTRE: PRETORIA 
 
SAHPRA is calling for applications from professionals who wish to serve on its RAG Committee for the term 2025 – 2028. The term may be renewed at the discretion of the Accounting Authority. 
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. 
RAG is a statutory committee, and candidates are expected to have an advanced understanding of the fiduciary duties as outlined in the Public Finance Management Act, 1 of 1999, Companies Act, 71 of 2008, and the Regulations thereof. SAHPRA subscribes to the King IV corporate governance principles and, as such, candidates must be familiar with the responsibilities and obligations as outlined therein. 
 
QUALIFICATIONS AND EXPERIENCE: 

• RAG serves as an oversight committee in relation to accounting and financial internal controls, compliance and risk management, and governance. 
• SAHPRA is seeking a suitably qualified professional with a high degree of integrity, ethical leadership, governance leadership competencies, and good interpersonal and communication skills who holds postgraduate qualifications of at least NQF Level 8 in the field of Accounting, Internal Auditing, Risk 
• Management and Governance, Financial Management, Technology and Information Governance. The candidate must possess qualifications as a CIA/CA (SA). 

 
The candidate must possess: 

• At least ten (10) years of experience serving on audit committees. 
• At least ten (10) years of experience in Supply Chain Management in public sector accounting, auditing, financial management, internal controls, and risk and compliance management. 

 
Applicants may not be in the employment of SAHPRA or a political office-bearer, and must have no business or personal relationship with the Authority. 
 
RESPONSIBILITIES WITHIN THE COMMITTEE: 
The Committee performs duties as required by Regulation 27.1 of the Treasury Regulations in terms of the PFMA and the RAG Charter which include, among others, the following: 

• Review annual financial statements and establish whether the statements have been prepared in accordance with the PFMA and related Treasury Regulations, including the applicable accounting frameworks. 
• Review the coordination of audit efforts to ensure the completeness of coverage and promote the effective use of financial resources. 
• Ensuring that the Committee serves as a mechanism of the Board of SAHPRA to monitor and reinforce the effectiveness of the internal control system and internal audit function. 
• Provide objective advice and recommendations to the management of the SAHPRA and the Board of SAHPRA regarding the sufficiency, quality and results of assurance on the adequacy and functioning of the entity's risk management, control and governance frameworks and processes (including accountability and auditing systems). 
• Provide advice and recommendations as may be requested by the on specific emerging priorities, concerns, risks, opportunities and/or accountability reporting. 
• Develop a direct, strong and candid relationship with the Auditor-General of South Africa. 

 
THE COMMITTEE MUST REVIEW AND MAKE RECOMMENDATIONS ON, AMONG OTHERS: 
• The functioning and overall efficiency and effectiveness of the internal controls system. 
• The functioning and effectiveness of the internal auditors. 
• The risk areas of the Authority’s operations to be covered in the scope of the internal and external audits taking the lead in identifying risks which may impact on the organisation and provide leadership in ensuring that there are processes in place to mitigate such risks. 
• The adequacy and effectiveness of the organisation’s internal controls, including computerised information systems control and security, the quality of financial and other management information produced to ensure integrity and reliability, as well as the related significant findings and recommendations of internal and external auditors, together with Management’s response thereto. 
Compliance with laws and regulations and other related requirements. 
 
 
CLOSING DATE: 02 MAY 2025
 
INSTRUCTIONS TO APPLICANTS: All applications must: 

• Be submitted with a cover letter outlining suitability for appointments, accompanied by a comprehensive CV, the names of three (3) referees, and certified copies of ID and qualification/s not older than three (3) months, and valid letter of good standing (unexpired) from the South African Institute of Chartered Accountants (SAICA) for the CA(SA) designation. 
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA). 
• Applications must be submitted by email to hr@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• No late applications will be accepted. CVs will not be returned. Applications received after the closing date and time will not be considered. 
• Communication will be limited to shortlisted candidates only. Applicants who have not been contacted within 3 months of the closing date may regard their application as unsuccessful. 
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA. 

 
 
Applicants must note that further checks (qualification verification and previous experience) will be conducted once they are appointed. 
 
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply, and an indication in this regard will be appreciated. 
 
Enquiries: Adv. Mpho Mphelo: Board Secretary, Email: mpho.mphelo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
 
 
 
 
 
 

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MANAGER: COMMUNICATION AND PUBLIC RELATIONS 
SALARY: R1 254 095 – R1 331 070 (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 11/2025 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric certificate and a tertiary qualification in Public Relations/Marketing/Communication at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA). A relevant postgraduate qualification or Health qualification will be an added advantage. A valid driver’s licence. 
 
EXPERIENCE: Minimum of eight (8) years of functional experience as a communication and public relations professional in the health sector, of which five (5) years must be in a senior communication leadership role. Working experience in the health sector will be an added advantage. 
 
REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS AND ABILITIES): * Comprehensive knowledge and understanding of relevant legislation, regulatory procedures. * Design and review of strategic plans, business plans and budgeting. * Team management. * Self-motivated and able to work independently. * Ability to manage a variety of cross-functional team members. * Competent in problem solving and team building. * Information evaluation. * Decision making. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Customer service. * Planning and organising skills. * Stakeholder management (Stakeholder mapping, relationship building). 
 
DUTIES: Strategic Management: Active participation and input into SAHPRA’s Strategic Plan. Draft, implement and manage SAHPRA’s Communication and Public Relations Strategic Plan. Serve as SAHPRA’s Spokesperson and manage all media relations activities. Develop and implement a comprehensive publication strategy aligned to SAHPRA’s strategic objectives and regulatory requirements. Lead and promote SAHPRA’s brand identity and values and ensure compliance with branding guidelines and regulatory requirements. Develop, implement and drive climate surveys with key internal and external stakeholders, and implement interventions to address gaps identified. 
Operational Management: Lead SAHPRA communication team and provide oversight, direction, content and corporate best practices. Develop and implement a communication and stakeholder relations strategy and policy (including media and stakeholder liaison). Develop and maintain systems and processes necessary for effective media interaction and communication between SAHPRA and key stakeholders. Plan, develop, execute and measure effective communications programmes, including media relations on health-related matters. Create results-driven communications related to regulatory compliance, pharmacovigilance and other regulatory initiatives that are measurable and help drive SAHPRA business objectives. Develop and communicate scientific regulatory content to make it accessible to the public in more “digestible” formats through a clear public engagement strategy. Educate and train SAHPRA employees on public relations, media, and social media so as to maintain a good public and service identity. Monitor media and social media so as to avert crisis situations from occurring, thereby ensuring SAHPRA's brand reputation. Proactively communicate any developments on health product regulations that have an impact on the public. Establish and maintain effective procedures for handling external stakeholder complaints. 
Financial Management: Develop and manage the Communication and Public Relations budget to ensure effective allocation of resources to drive strategic objectives. Monitor expenses, track performance metrics, and provide regular and timeous reports to EXCO. Drive cost-saving initiatives across the business unit. Ensure compliance with SAHPRA’s Policies, PFMA/Regulations and Treasury directives. 
Governance, Compliance and Risk: Manage quality assurance measures and adherence to quality standards. Construct and monitor reliable control systems. Ensure implementation and adhere to all Communications and Media Management processes and quality assurance requirements. Communication and Branding framework and requirements. Development and implementation of Communication and marketing SOPs and policies. Effective management of reputational, financial and legal risks. 
People Management: Drive a high-performance culture within the Communication and Public Relations team. Drive a culture of personal and professional development. Living the SAHPRA Values. Drive collaborative leadership. 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources. 
• Should you be in possession of 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 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 South Africa (1996), 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: SAHPRA website (https://www.sahpra.org.za) – About Us – Vacancies. 
 
For enquiries: Please contact Ms Setlola Molepo, via email at Setlola.Molepo@sahpra.org.za.
 
NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
 
The closing date is 02 May 2025 at 16H00. 
 
 
 
 
 
 

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MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION 
(PHARMACEUTICAL EVALUATION MANAGEMENT) (FIXED TERM CONTRACT: UNTIL 30 SEPTEMBER 2025) 
SALARY: R700 105.00 – R888 422.00 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 19/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Applicants must be in possession of a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) 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. 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 at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of three (3) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years’ regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
Grade 2: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
 
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 and efficacy (bioequivalence) of medicines. *Computer literacy and 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: *Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with required template and adopted regulatory/scientific standards 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. 
● Evaluate applicant responses for registration/approval of medicines: *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. *Following the peer-review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. *Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. *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 for approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
●Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: *Generate technical screening evaluation reports for each application and submit for peer-review. *Following the peer-review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening reports compiled by other reviewers. *Prepare screening query/screening rejection letters to applicants. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
● Develop and update guidelines, SOPs and templates: *Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. *Provide training on guidelines, SOPs and templates. *Create new guidelines, SOPs and templates where relevant. *Provide regular workplans and output to the unit manager (qualitative and quantities report). *Perform any other related duty as requested by the manager/senior manager. 
● Form part of technical working groups or special projects and also provide support to the unit as well as to advisory committees: *Participate in special projects and registration groups. *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. *Create and maintain databases. *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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards. 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources. 
• Should you be in possession of 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 02 May 2025 at 16:00. 
 
 
 
 
 
 

​MEDICINE REGISTRATION OFFICER: HEALTH PRODUCTS AUTHORISATION: RENEWALS X2 
SALARY: R 700 105.00 – R888 422.00 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. 
Ref No.: SAHPRA 015/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: •Matric certificate and appropriate four-year degree in Pharmacy or relevant Natural Sciences at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), and registration with a statutory council. A relevant Master’s degree will be an added advantage. A valid driver’s licence. 
Grade 1 – A minimum of two (2) years of regulatory experience (post community service). Knowledge of the technical evaluation of the quality, safety and efficacy aspects of medicines. 
Grade 2 - A minimum of five (5) years of regulatory experience (post community service). Knowledge of the technical evaluation of the quality, safety and efficacy aspects of medicines. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: *Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. *Knowledge of the requirements for medicine Product Quality Reviews, the associated technical aspects of manufacturing and relevant Good Manufacturing Practices, as per SAHPRA GMP. *Knowledge of technical aspects for the evaluation of the quality and efficacy of bioequivalence of medicines. *Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. *Good planning, organisational and interpersonal skills. *Self-motivated and able to work independently. *Decision-making informed by technical expertise. *Good communication skills (written, verbal, negotiation, conflict management, presentation). *Innovative thinking, initiative, assertive and leadership qualities. *Dedication and accurate work. *Ability to manage a variety of cross-functional team members. *Ethical behaviour. *Computer skills (knowledge of MS Office). *Must be willing to travel and work irregular hours. *Customer service. 
 
DUTIES:

• Evaluation and peer-reviewing of renewal applications: *Evaluate and generate evaluation report(s) for renewal applications (generics) in compliance with required template and adopted regulatory and scientific standards as per Good Manufacturing Practice (GMP) Pharmaceutical Inspection Co-operation Scheme (PIC/s) guidelines, European Medicines Agency (EMA) renewal guidelines, etc., and submit for peer review. *Peer review evaluation reports in compliance with good review practice and draft peer reviewed report. *Request Quality Assurance (QA), expert advice or send to technical committee meeting if necessary and submit signed report for filing and further processing. *Following peer review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Prepare reports or memos for the internal working groups. *Prepare query letter to the applicant. *Provide QA of reports and facilitate resolutions on technical matters. 
• Evaluate applicant responses of renewal applications: *Evaluate and generate second (and subsequent) evaluation report(s) for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. *Peer review other evaluators’ response reports according to the required template and adopted regulatory/scientific standards. *Prepare reports and record outcomes for the internal working groups, technical meetings or committee meetings. *Prepare query letters to the applicants. *Provide QA reports and facilitate resolutions on technical matters. 
• Technical screening of renewal applications: *Generate technical screening evaluation report(s) for each application and submit for peer review. *Following the peer review process, amend the technical screening report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening report(s) done by other reviewers. *Prepare screening query/screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate matters. 
• Develop and update guidelines, SOPs, and templates: *Review existing guidelines, Standard Operating Procedures (SOPs) and templates, and update when necessary. *Provide training on guidelines, SOPs, and templates. *Create new guidelines, SOPs, and templates where SOPs are not in place. *Provide regular work-plans and output to the unit manager (qualitative and quantitative report). *Perform any other related duty as requested by the manager/senior manager. 
• Participate in technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: *Participate in special projects as and when necessary based on the technical and operational needs of the unit. *Lead and manage assessments, peer review and discussion working groups where relevant. *Compile discussion documents and reports. *Take comprehensive notes of discussions of relevant discussions. 
• Risk Management and Audit: *SOPs and guidelines must be adhered to. *Create and maintain databases. *Use the most current templates and guidelines. *Provide and attend relevant training that may be necessary. * Align with Quality Management System (QMS) requirements. *Align with International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (ICH/VICH), World Health Organisation (WHO) and international standards and use the most current SAHPRA templates and guidelines. 

 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources. 
• Should you be in possession of 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 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), 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: SAHPRA website (https://www.sahpra.org.za/vacancies). 
 
For enquiries: Please contact Ms Setlola Molepo, via email at setlola.molepo@sahpra.org.za.
 
NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 
 
The closing date is 02 May 2025 at 16:00.

​MEDICINES REGISTRATION OFFICER: POST-REGISTRATION 
(PHARMACEUTICAL EVALUATION MANAGEMENT) (FIXED TERM CONTRACT: UNTIL 30 SEPTEMBER 2025) 
SALARY: R700 105.00 – R888 422.00 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 18/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Applicants must be in possession of a Matric certificate and appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) 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. 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: 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) plus a minimum of three (3) years’ experience (post community service) in a Regulatory, Quality Assurance or Production environment; OR Honours Degree in related health Sciences at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience in a Regulatory, Quality Assurance or Production environment. 
Grade 2: 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) plus a minimum of five (5) years’ experience (post community service) in a Regulatory, Quality Assurance or Production environment; OR Honours Degree in related health Sciences at NQF level 8 as recognised by SAQA plus a minimum of eight (8) years’ experience in a Regulatory, Quality Assurance or Production environment. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Performance measurement skills. Self-motivated and able to work independently. 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). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Team management. 
 
DUTIES: Evaluation of quality variations for small molecule product applications and peer-reviewing of these applications. Write reports and draft query and approval/rejection letters after evaluation: Evaluation of Type I and II quality variation applications in accordance with EMA variation guidelines, ICH requirements and minimal international standards. Prepare a detailed scientific evaluation report in accordance with the Good Review Practice guide and competency assessment rubric. Peer-review reports done by other reviewers in accordance with the Good Review Practice guide and competency assessment rubric. Do a QA check or technical discussion on evaluation reports, in cases where this is needed. Prepare report for the internal peer review or technical discussion meetings and where necessary present at advisory committee. Prepare draft query, approval or rejection letter to the applicant, whichever is relevant. Check letters for correctness for technical requirements and for spelling, grammar and sentence construction. 
Technical screen and evaluate the quality and efficacy (Bio-equivalence) aspects of the quality variation applications for the registered medicines: Complete technical screening of all new variations received in accordance with technical screening SOP and record on the tracker. Generate screening/evaluation query letter for relevant technical queries. Complete technical screening, check on the validation template and draft templates for evaluators, and save these on the shared drive in the application specific folder. Complete admin screening and verify fees, by calculating required fees. Record the fees paid as per the POP in the dossier, in the tracker and communicate shortfalls via unit email. Create POP folder on the shared drive for each new sequence and save POPs. Update the tracker with the above information and the payments which were made in response to queries sent to the applicant. 
Evaluate applicant responses and variations for the registered medicines: Evaluate the quality and efficacy (Bio-equivalence) aspects of responses to queries on the variations to registered products, in line with Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. Generate detailed scientific evaluation reports in line with the Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. Prepare report for the internal peer review and where necessary present at advisory committee. Prepare approval/query/rejection letter as applicable. 
Form part of technical working groups or special projects and also provide support to the Advisory Committees: Participate in special projects and Pre and Post registration working groups as required and engage in technical scientific discussions on ongoing applications under review. Lead and manage (including organising) assessments peer review and discussion working groups, where relevant, and do research if necessary to contribute to the discussions. Compile discussion documents, including agendas, minutes and actions items, and reports. Update these regularly as necessary. Record meetings and save in the unit shared drive. Take comprehensive notes of discussions of relevant discussions in meetings and update documents regularly. Implement any scientific decisions in future assessments. Participate in international scientific regulatory forums and discussion groups including ICH, IPRP and WHO, as relevant and when nominated. 
Risk Management and Audit: SOPs and SAHPRA, ICH, EMA and other relevant guidelines must be adhered to. Create and maintain data bases as needed. Respond to relevant queries timeously. Respond to applicants’ questions pertaining to recommendations and any other related concerns. Attend relevant training as may be necessary and give feedback to the unit after attendance. Provide training and mentorship for other staff members if relevant - this includes technical scientific trainings as well as practical administrative trainings. Keep updated on regulatory updates and latest scientific discussions and alerts with regards to medicines quality, safety and efficacy. 
Develop and update guidelines, SOPs and templates: Review existing SOPs and update when necessary. Provide comments and corrections to SOPs which are currently under review. Create new SOPs where relevant or as instructed by the manager. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager.
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources. 
• Should you be in possession of 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 was 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 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: https://www.sahpra.org.za – About Us – 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 02 May 2025 at 16:00.