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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

 

IMPORT APPROVAL MEDICINES CONTROL TECHNICIAN X 6

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R563 996.00 PER ANNUM (TOTAL COST TO COMPANY)

REF NO.: SAHPRA 14 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: ●Applicants must have a Matric certificate and Advanced Certificate: PharmacyTechnical Support qualification and registered with the South African Pharmacy Council (SAPC) as per the latest Pharmacy Act Regulations.

 

EXPERIENCE: ●Minimum of two (2) years of relevant experience Post Traineeship, ●Knowledge of medical products quality assurance including interpretation, evaluation and analysis of health products regulatory compliance and inform decision-making.

 

COMPETENCIES, KNOWLEDGE AND SKILLS: *Comprehensive and sound knowledge of relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act No. 101 of 1965 as amended. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management resolution) *Resilience. *Delivery of service objectives with professional excellence and efficiency. *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. *Working knowledge of MS Office. *Valid driver’s licence. *Ethical behaviour and adherence to the SAHPRA code of conduct.

 

DUTIES: ●To receive, review, assess, and process applications for import authorisation permits in accordance with applicable legislation, regulations, policies, and procedures. The role ensures that no person or entity imports regulated goods without a valid permit issued by SAHPRA .

Application Management: ●Receive and register applications for import authorisation permits, ●Verify that all required documents and supporting information are submitted, ●Maintain accurate records of applications, approvals, rejections, and correspondence, ●Acknowledge receipt of applications and communicate application status to applicants.

Review and Assessment: ●Review applications for completeness, accuracy, and compliance with legal and regulatory requirements, ●Assess applicant eligibility in accordance with governing legislation and internal procedures, ●Evaluate supporting documentation, including licences, certificates, invoices, and other regulatory submissions, ●Identify non-compliant, incomplete, or fraudulent applications and recommend corrective action.

Approval and Permit Processing: ●Recommend approval, rejection, suspension, or withdrawal of import authorisation applications based on findings, ●Prepare permits and related documentation for authorisation by the designated authority, ●Ensure permits are issued within prescribed timelines and conditions, ●Monitor compliance with permit conditions and regulatory requirements.

Compliance and Regulatory Enforcement: ●Ensure adherence to the legal requirement that no person or entity shall import regulated goods unless a valid permit has been issued by SAHPRA ●Interpret and apply relevant legislations, regulations, policies, and operational guidelines, ●Liaise with SAHPRA Port Officials, Border Management Authority, Customs Officials, law enforcement agencies, and other stakeholders where necessary, ●Assist with investigations relating to unauthorised imports or permit irregularities.

Reporting and Administration: ●Prepare reports, statistics, and summaries on permit applications and approvals. ●Maintain confidential and secure records in accordance with data protection and records management requirements, ●Support audits, inspections, and compliance reviews, ●Participate in process improvement initiatives and policy implementation.

 

 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):

 Interested candidates who meet the above requirements should submit their 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, that will be communicated by Human Resources Unit.

 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 


 

 

 

 

 

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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

MEDICINES CONTROL OFFICER: CONTROL OF PROMOTIONS, MARKETING MATERIALS AND ADVERTS GR 1 X 2

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R738 611.00

REF NO.: SAHPRA 13 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or Bachelor of Science degree in Pharmacology or equivalent as recognised by SAQA. Where applicable active Registration with statutory council e.g. Pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA). Valid driver’s licence.

 

EXPERIENCE: Minimum of three (3) years of relevant experience practising in the pharmaceutical regulatory environment post community service for pharmacist. Experience in pharmaceutical compliance, regulatory affairs, or in reviewing and approving pharmaceutical marketing and advertising materials, or in investigating advertising complaints and post-marketing surveillance cases, or exposure to social media monitoring and digital trend analysis within the healthcare or pharmaceutical sector or working with regulatory authorities.

 

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 •Regulatory framework development or policy writing •Solid understanding of pharmaceutical marketing practices and compliance requirements •Knowledge of cybersecurity principles relating to data protection and digital risk management •Knowledge in monitoring and reporting on social media trends in the pharmaceutical or healthcare environment will be an advantage •Investigational, analytical, and problem-solving skills, •Ability to manage multiple priorities in a fast-paced environment.

 

DUTIES: Operational Management: •Ensure compliance with the provisions of the Medicine and Related Substances Act No. 101 of 1965 as amended, through the implementation of strategies for preventing, detecting and responding to substandard, falsified, unregistered, unauthorized health products in the market.

Key activities for this function include advertisements, promotions and marketing Regulatory Review and Compliance, Scientific and Medical Accuracy Verification, Risk - Benefit Communication Assessment, Cross-functional Collaboration, Documentation and Audit Readiness and include:

a) Help the development of Regulations in terms of Section 18C and all related activities as determined by the management.

b) Review, consider, examine and correct all promotional material, event, meeting, interaction proposals and/or any other material relevant to Compliance to ensure complete compliance with the provisions of the Medicines and Related Substances Act No. 101 of 1965 as amended, in alignment with legislation such as the Pharmacy Act No. 53 of 1974 and any other applicable legislations.

c) Review, consider, evaluate artwork elements and ensure compliance with specified guidelines, dossier requirements, internal policies and standards.

d) Review and approve sample requests against the requirements of the relevant Acts, regulations, rules and standards.

e) Provide training to applicants and fellow colleagues to ensure compliance with the applicable sections of the Legislation , Regulations, Schedules and Codes as well as competence and compliance with internal policies, guidelines and SOPs.

f) Drive and enforce compliance with the provisions of Section 18, Schedules and Regulation 42 and any applicable compliance requirements.

g) Ensure that the agreed timelines and key performance indicators for these processes are consistently being adhered to.

h) Participate in knowledge transfer and coordinate internal programmes meetings to discuss and resolve promotions, adverts and marketing matters.

i) Be able to interpret and understand changes affecting regulations and guidelines and to guide or facilitate implementation at an operational level.

j) Be proactive in continual operations improvement relating to promotions, adverts and marketing matters for industry updates and implementation.

k) Participate in internal self- and external audits as required.

Governance, Compliance and Risk: •Achieve and maintain process quality •Adherence with the OHSA to ensure a safe and 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 Business 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 Business Unit •Identify and record operational risks and consult with Business 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 up to the SAHPRA values •Sharing knowledge and 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 administration •Monitor and maintain all required financial records for compliance and audit to all agreed requirements •Collate financial data and reports for analysis and to facilitate decision making.

Stakeholders: •All SAHPRA Business Units , Core and Non-core e.g. Inspectorate, Licencing, Medical Device, CAMs, N&S Comms, HR, legal and HPA, PV, Clinical trials, Clinical Pre/Post Registration, PEM, CEM, Biological, Radiation Control, Unregistered Products/Section 21, Veterinary Medicines, Human Resources Unit, Finance, ICT, Legal, Laboratory Management.

External: •SAPC, BMA, SARS Customs, SAVC, DPCI, NDA , SAPS, NDoH, HPCSA, SANC and SAPC, ISPA, Cyber Security, Department of Communication and Digital Technologies, NPA, Applicants, pharma crime, Consumer Protection, CIPC, Pharma Industry, Provincial Departments of Health (PDoH), Members of the Public, Media, International Organisations, PICs, Regional/International Harmonization Initiatives World Health Organisation (WHO), National Regulatory Authorities (NRAs), International Regulatory Authorities.

 

 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):

 Interested candidates who meet the above requirements should submit their 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 

 

 

 

 

 

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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

 

MEDICINES CONTROL OFFICER: CONTROL OF IMPORT AUTHORISATIONS AND INSPECTIONS GR 1 X 2

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R738 611.00 PER ANNUM (TOTAL COST TO COMPANY)

Ref No.: SAHPRA 12 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: •Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or Bachelor’s degree in a scientific field such as Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related discipline. NQF Level 8 as recognised by the South African Qualifications Authority (SAQA). Where applicable active Registration with statutory council e.g. Pharmacist with the South African Pharmacy Council (SAPC), Valid driver’s licence.

 

EXPERIENCE: •Minimum of three (3) years of relevant experience in practising in pharmaceutical regulatory environment post community service for pharmacist or related environment. •Experience in regulation of import or export control, regulatory affairs, or in reviewing permits, licences, or regulatory applications is advantageous.

 

COMPETENCIES, KNOWLEDGE AND SKILLS: *A solid understanding of application procedures. *Medicines Act as Amended and its Regulations. * Timely review and processing of import permit applications. *Compliance with legislative and regulatory requirements. *Accuracy and quality of scientific evaluations*Effective supervision and team performance. *Stakeholder satisfaction and responsiveness. *Proper maintenance of records and reporting systems. *Consolidated Schedules. *Strong analytical and scientific evaluation skills. *Excellent report writing and communication skills. *Attention to detail and sound decision-making ability. * Supervisory skills. *Ability to interpret and apply legislation and policies. *Organisational and time-management skills. *Proficiency in relevant computer systems and databases. *Planning and organisational skills. *Interpersonal skills. *Investigation skills. *Computer skills and knowledge of MS Office. *Drive and self-management skills.*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*, regulatory framework development, or policy writing

 

DUTIES: Regulatory Review and Approval: •Ensure all regulation and policy updates requirements, reviews are correctly implemented in consultation with management •Oversee that all processes and procedures for import authorisations are in place and up to date •Ensure industry is kept abreast and consultation is effected where required •Review and evaluate applications for import authorisation permits to ensure compliance with applicable laws, regulations, standards, and policies, •Verify the scientific, technical, and regulatory accuracy of submitted documentation and supporting information •Assess risks associated with imported products, substances, materials, or equipment •Approve, reject, or recommend amendments to import permit applications in line with legislative requirements and delegated authority •Ensure that import authorisations are issued only where all statutory requirements have been adhered to.

Legislative Compliance: •Enforce legislation stipulating that no person shall import regulated products or materials unless authorised by a permit issued by SAHPRA. •Interpret and apply relevant legislation, regulations, guidelines, and standard operating procedures, •Maintain up-to-date knowledge of changes in import control laws, scientific standards, and regulatory frameworks.

Stakeholder Engagement: •Liaise with Applicants or importers, government agencies, laboratories, inspectors, and other stakeholders regarding permit requirements and compliance matters •Respond to queries relating to import authorisation processes and regulatory requirements •Participate in inspections, investigations, and audits where necessary.

Recordkeeping and Reporting: •Maintain accurate records of applications reviewed, permits issued, rejected applications, and compliance actions, •Prepare technical and regulatory reports for management and SAHPRA, •Ensure confidentiality and integrity of regulatory information and documentation.

Quality Assurance and Risk Management: •Monitor compliance trends and identify potential regulatory risks •Contribute to the development and review of policies, procedures, and regulatory systems •Support continuous improvement initiatives within the import authorisation process.

Governance, Compliance and Risk: •Achieve and maintain process quality •Adherence with the OHSA to ensure a safe and healthy working environment •Ensure adherence to all process quality assurance requirements •Compile SOPs, Review SOPs and Guidelines as per QMS requirements •Assist with Performance Reporting within the predetermined timeline •Identify and record operational risks and consult with the Business Unit Manager •Mitigate risks within operational environment •Resolve 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 Business Unit •Identify and record operational risks and consult with the Business Unit Manager. People Management: •Supervise and guide import technicians and regulatory staff involved in permit evaluation processes •Allocate work, monitor performance and ensure adherence to turnaround times and quality standards •Provide technical support and mentorship to junior staff members •Self-management •Manage own Performance and Individual Development Plan •Living up to the SAHPRA values •Sharing knowledge and informal coaching to other peers (as applicable) •Support other fellow 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

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 ability 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 administration •Monitor and maintain 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 their 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 

 

 

 

 

 

 

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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

MEDICINES CONTROL OFFICER: POST MARKET SURVEILLANCE GR 1 X 2

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R738 611.00 (TOTAL COST TO COMPANY)

REF NO.: SAHPRA 11 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or Bachelor of Science degree in Pharmacology or equivalent as recognised by SAQA. Where applicable active Registration with statutory council e.g. Pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA). Valid driver’s licence.

 

EXPERIENCE: Minimum of three (3) years of relevant experience practising in pharmaceutical regulatory environment (post community service for pharmacist). Experience in pharmaceutical compliance, regulatory affairs, or in reviewing and approving pharmaceutical marketing and advertising materials, or in investigating advertising complaints and post-marketing surveillance cases, or exposure to social media monitoring and digital trend analysis within the healthcare or pharmaceutical sector or working with regulatory authorities

 

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 *Regulatory framework development, or policy writing *Solid understanding of pharmaceutical marketing practices and compliance requirements *Knowledge of cybersecurity principles relating to data protection and digital risk management *Knowledge in monitoring and reporting on social media trends in the pharmaceutical or healthcare environment will be an advantage * Investigational, analytical, and problem-solving skills *Ability to manage multiple priorities in a fast-paced environment.

 

DUTIES: Operational Management: Ensure compliance with the provisions of the Medicine and Related Substances Act No. 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 Post-Market Surveillance (PMS)

 Evaluate risks relating to the quality, safety, and efficacy of health products available to the public.

 Prepare documentation, coordinate logistics, and ensure readiness for PMS Technical Working Group (TWG) meetings while serving as Secretariat.

 Proactively develop, monitor, and review PMS protocols and plans.

 Compile annual PMS reports and submit monthly, quarterly, and annual performance reports to management.

 Coordinate physical sample collection across various levels of the supply chain.

 Ensure execution of the PMS sample collection plan in line with approved PMS plans.

 Liaise with public and private facilities to obtain required information and permissions.

 Collaborate with internal stakeholders on PMS sampling and testing activities.

 Maintain PMS databases and ensure accurate record keeping.

 Ensure proper chain of custody and sampling documentation during all sampling activities.

 Coordinate with the Laboratory Services Manager regarding outsourced activities and report non-compliance with Service Level Agreements (SLAs) and compliance standards.

 Confirm availability of data logger downloads for each sampling activity.

 Evaluate analytical testing results and prepare analytical reports.

 Analyse PMS data and support regulatory decision-making.

 Initiate issuance of certificates to healthcare representatives (HCRs) and facilities where PMS samples were collected and tested.

 Assist in drafting and reviewing Standard Operating Procedures (SOPs) for PMS functions.

 Define study objectives and identify specific concerns for investigation within the PMS programme. 

Governance, Compliance and Risk: *Achieve and maintain process quality. *Adherence with the OHSA to ensure a safe and 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 Business Unit Manager. *Mitigate risks within operational environment. *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 Business Unit. *Identify and record operational risks and consult with Business 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 up to the SAHPRA values. *Sharing knowledge and informal coaching to 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 ability to communicate key financial messages to stakeholders with clarity and consistency. *Provide general advice on all finance matters to all affected colleagues involved, directly or indirectly, in the financial administration . *Monitor and maintain 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 their 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 

 

 

 

 

 

 

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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

 

MEDICINES CONTROL OFFICER: TRACEABILITY GR 1 X 2

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R738 611.00 PER ANNUM (TOTAL COST TO COMPANY)

REF NO.: SAHPRA 10 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or Regulatory Science, Biomedical Science, Public Health, Chemistry, Biotechnology Data Science, Supply Chain Management, or related discipline is an added advantage. NQF Level 7 or 8 as recognised by the South African Qualifications Authority (SAQA). Where applicable active Registration with statutory council e.g. Pharmacist with the South African Pharmacy Council (SAPC), Valid driver’s licence. Registration with a recognized professional body where applicable.

 

EXPERIENCE: Minimum of three (3) years of relevant experience practising in pharmaceutical regulatory environment (post community service for pharmacist) or related environment. Experience in medicines regulation, pharmacovigilance, quality assurance, supply chain management, or regulatory compliance. Experience with traceability systems, serialization, barcoding, GS1 standards, or digital health technologies is desirable. Knowledge of World Health Organisation (WHO) guidelines, Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and regulatory frameworks for medical products. Experience in data analysis, regulatory inspections, or post-market surveillance is an advantage.

 

COMPETENCIES, KNOWLEDGE AND SKILLS: *A solid understanding of application procedures. *Medicines Act as Amended and its Regulations. * Strong analytical and scientific evaluation skills*Knowledge of medical products regulatory systems*Excellent report writing and communication skills *Ability to interpret legislation and technical standards *Problem-solving and investigative skills. *Proficiency in data management and digital systems. *Ability to work collaboratively with multidisciplinary teams. *High ethical standards and attention to detail. *Accuracy and quality of scientific evaluations*Stakeholder satisfaction and responsiveness. *Proper maintenance of records and reporting systems. * Attention to detail and sound decision-making ability. * Planning and organisational skills. *Interpersonal skills. *Investigation skills. *Computer skills and knowledge of MS Office. *Drive and self-management skills.*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* Regulatory framework development, or policy writing

 

DUTIES: Operational Management: Effective implementation of traceability systems, timely review and reporting of regulatory data. Reduction in circulation of falsified and substandard products. Compliance monitoring and stakeholder engagement outcomes. Contribution to policy and regulatory improvements. Develop and implement regulatory frameworks and guidelines for traceability of medical products. Monitor compliance with traceability regulations for pharmaceuticals, vaccines, medical devices, and other health products. Support implementation of serialization and track-and trace technologies within the healthcare supply chain. Conduct scientific and regulatory assessments of traceability systems and digital identification technologies. Collaborate with manufacturers, importers, distributors, healthcare institutions, customs authorities, and international partners on traceability initiatives. Investigate incidents related to falsified, substandard, diverted, or counterfeit medical products. Analyse regulatory and surveillance data to identify risks and recommend corrective actions. Participate in inspections, audits, and post-market surveillance activities. Prepare technical reports, regulatory recommendations, and policy documents. Ensure alignment with WHO, regional, and international regulatory standards and best practices. Provide technical training and stakeholder awareness on traceability systems and regulatory requirements. Contribute to continuous improvement of digital regulatory systems and databases.

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 ability to communicate key financial messages to stakeholders with clarity and consistency. Provide general advice on all finance related matters to all affected colleagues , directly or indirectly, in the financial administration. Monitor and maintain all required financial records for compliance and audit to all agreed requirements. Collate financial data and reports for analysis and to facilitate decision making,

Governance, Compliance and Risk: Achieve and maintain process quality. Adherence with the OHSA to ensure a safe and healthy working environment. Ensure adherence to all process quality assurance requirements. Assist with Performance Reporting within the predetermined timelines. Identify and record operational risks and consult with the Business Unit Manager. Mitigate risks within operational environment. 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 Business Unit.

People Management: Self-management. Manage own Performance and Individual Development Plan. Living up to the SAHPRA values. Sharing knowledge and informal coaching other peers (as applicable)

 

 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):

 Interested candidates who meet the above requirements should submit their 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 

 

 

 

 

 

 

 

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 monitor, evaluate , regulate , investigate , inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

 

 

MEDICINES CONTROL OFFICER: INVESTIGATIONS GR 1 X 2

(FIXED TERM CONTRACT: UNTIL 30 JULY 2029)

SALARY: R738 611.00 PER ANNUM (TOTAL COST TO COMPANY)

REF NO.: SAHPRA 09 OF 2026/27

CENTRE: PRETORIA

 

REQUIREMENTS: Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree or bachelor’s degree in law (Preferably LLB) at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA). Where applicable active Registration with statutory council e.g. Pharmacist with the South African Pharmacy Council (SAPC), Valid driver’s licence.

 

EXPERIENCE: Minimum of three (3) years of relevant experience in practising pharmaceutical regulatory environment (Pharmacists: Three (3) years post community service for pharmacist)

 

COMPETENCIES, KNOWLEDGE AND SKILLS: *A solid understanding of application procedures. *Medicines Act as Amended and its Regulations. *Consolidated Schedules. *Strong analytical and scientific evaluation skills. *Excellent report writing and communication skills. *Attention to detail and sound decision-making ability. * Supervisory skills. *Ability to interpret and apply legislation and policies. *Organisational and time-management skills. *Proficiency in relevant computer systems and databases. *Planning and organisational skills. *Interpersonal skills. *Investigation skills. *Computer skills and knowledge of MS Office. *Drive and self-management skills. *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*Regulatory framework development, or policy writing.

 

DUTIES: Operational Management: Ensure compliance via preventing, detecting and responding to substandard, falsified, unregistered, unauthorized health products, facilities and personnel:

o Import and export,

o Adverts and promotions,

o Alerts and recalls,

o Seizures and destructions,

o Sections 36 exclusions

o Donations

o Post-Market Surveillance Sampling and Testing of health products

o Investigations of non-compliance

o Attend operations or raids

o Attend to court

o Stakeholders’ management

o Administrative and Technical Support Narcotics and Psychotropics substances

a) Compliance Monitoring and Enforcement:

o Investigate and report on compliance and non-compliance.

o Conduct inspections, raid and initiate legal actions as needed.

o Sample and test products to ensure quality standards are met.

o Collaborate with law enforcement, other agencies, and international organizations.

o Process and manage license applications (new, renewal, amendment, revocation).

o Monitor and respond to recalls and alerts.

o Monitor and enforce compliance of adverts & promotions

o Manage escalated port import/export enquiries

o Attend to courts

b) Data Management and Reporting:

o Prepare various reports in point a). (monthly performance, quarterly, annual, INCB reports, etc.).

o Maintain relevant databases.

o Analyse data for decision-making.

o PMS Annual report

c) Stakeholder Management:

o Develop and maintain relationships with internal and external stakeholders.

o Conduct regular meetings and training sessions.

o Participate in BMA, SARS, SAPS HPCSA and SAPC engagement sessions in alignment with MOUs.

o Attend meetings, conferences and briefings with stakeholders including workshops and training overseas.

o Support the initiatives of stakeholders which are relating to contravention of the Medicines Act.

o Support the Communication department’s queries relating to media.

o Training of stakeholders.

o Consult with internal core business and support units whenever applicable (Manager, Senior Manager, Executive Management, Advisory Committees, CAMS, Medical Device Unit, Section 21, Names and Scheduling, Veterinary, Biological).

d) Post-Market Surveillance (PMS):

o Plan and execute PMS activities.

o Manage sampling and testing.

o Report findings and collaboration with laboratories.

e) Administrative and Technical Support:

o Provide administrative and technical support within the unit.

o Assist with queries and provide guidance.

f) Narcotics and Psychotropic substances management- annual Estimates, import, export possession, inspections, use and reports are aligned with the UN- international narcotics control conventions requirements

g) Section 36 and Donation management

h) Destructions of health products and for controlled substances

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 ability to communicate key financial messages to stakeholders with clarity and consistency.

Provide general advice on all finance matters to all affected colleagues involved, directly or indirectly, in the financial administration. Monitor and maintain all required financial records for compliance and audit to all agreed requirements. Collate financial data and reports for analysis and to facilitate decision making.

Governance, Compliance and Risk: Achieve and maintain process quality. Adherence with the OHSA to ensure a safe and healthy working environment. Ensure adherence to all process quality assurance requirements. Assist with Performance Reporting within the predetermined timelines. Identify and record operational risks and consult with the Business Unit Manager. Mitigate risks within operational environment. Resolve 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 Business Unit.

People Management: Self-management. Manage own Performance and Individual Development Plan. Living up to the SAHPRA values. Sharing knowledge and informal coaching to other peers (as and when applicable).

 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):

 Interested candidates who meet the above requirements should submit their 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 are encouraged to apply and indicate their disability status.

 SAHPRA reserves the right not to make any appointment to the advertised post.

 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 29 May 2026 at 16:00.

 

 

 

 

 

 

 

 

 

 

 

 

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 monitor, evaluate, regulate, investigate, inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest. 

 

Please note that this is a re-advertisement, and candidates who previously applied are encouraged to re-apply. 

 

SENIOR MANAGER: MEDICAL DEVICES AND RADIATION CONTROL 

(RE-ADVERTISEMENT)

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 or Clinical Engineering or 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 No. 101 of 1965 as amended, and its Regulations; the Hazardous Substances Act No. 15 of 1973; and the National Health Act No. 61 of 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 No. 101 of 1965 as amended and the regulations pertaining to the Act and the Hazardous Substances Act No. 15 of 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 In Vitro Diagnostics, 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 and national protocols and relevant legislations. 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 (including in vitro diagnostics), radiation-emitting devices, radionuclides, and radiation generation. Share critical updates (e.g., strategy/legislative changes). 3 Re-Advertisement: Senior Manager: Medical Devices and Radiation Control 

 

Local and International Stakeholder Engagement: Liaise with both local and international regulators and stakeholders to ensure accurate information exchange and productive relationships. Ensure active South African health 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 29 May 2026

 

 

 

 

 

 

 

 

 

 

 

 

CALL FOR EXPRESSION OF INTEREST 

GOOD MANUFACTURING PRACTICE EXTERNAL EVALUATORS 

 

The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for the Inspectorate Unit. 

SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials. 

 

REQUIREMENTS

The External Evaluators are appointed in terms of Section 3(5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority in the area of GMP Medicines Evaluation. Expression of interest is required for experts who are already familiar with PICs, ICH, SAHPRA and other recognised relevant international requirements for medicines as well as eCTD dossier reviews for both new medicines registrations and variations such that they are able to commence with immediate effect. 

Expression of interest is required in the following disciplines: 

• Four (4) external evaluators for the Inspectorate Unit in Programme 3: Inspectorate and Regulatory Compliance. 

 

Experience and knowledge in the following will be an added advantage: 

- National Regulatory Authority experience within GMP evaluation or GMP expertise. 

- Reviewers who have review experience in National regulatory authorities (minimum 3 years in GMP medicines reviews). 

- Experience in medicines regulations and understanding of new registration, variations, and GMP requirements. 

- Familiarity with SAHPRA regulations and procedures for medicine registration. 

 

Duties:

- Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Interpretation and implementation of relevant PICs, ICH guidelines, SAHPRA and other recognised relevant international requirements. 

- Assess GMP related compliance of applications as determined by the unit relating to but not limited to; 

- Evaluation of applications for New Registrations. 

- Desktop review for applications relating to Good Manufacturing Practice Certificates (GMP). 

- Evaluation of applications for Certificate of Pharmaceutical Product (CPP) & Good Manufacturing Practice Certificates (GMP). 

- Evaluations for Variations: Type I and Type II. 

- Evaluation of Once off deviations within prescribed GMP requirements. 

- Report writing for SAHPRA and relevant advisory committees. 

- Understanding of Good Manufacturing Practice principles and application. 

- Evaluate Pre- and Post- Registration information submitted in a medicine application form (eCTD). 

 

Output expected from the incumbent: 

 

Minimum of four (4) hours daily solely dedicated to this function for productivity expected to meet the performance targets in line with organisational targets. 

EXCLUSIONS:

- Where such person is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (OF-GOV-02B). 

- Is disqualified under the Relevant Act applicable to his or her profession from practising as such. 

- Has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act. 

- Is a patient as defined in the Mental Health Care Act, 2002 (Act No. 17 of 2002), as amended. 

- Has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud. 

- Does not meet the minimum requirements. 

 

RELEVANT QUALIFICATIONS 

Appropriate Degree in Pharmacy/Pharmaceutical Sciences, or other relevant Sciences. 

Registration with the statutory regulatory board/council relating to his/her profession where applicable is recommended. 

Applicant must be in good standing with the regulatory board/ council with which he/ she is registered where applicable. 

 

TERM OF OFFICE 

The term of service for External Evaluators will be from date of appointment until 31 October 2027. External Evaluators may be appointed for a further extension of term(s). 

 

PROCEDURE

• A comprehensive CV, qualification/s and a motivation expressing area of expertise must be submitted online at https://apply.sahpra.org.za:6006/ 

• Only documents in pdf must be uploaded. 

• Further communication will be limited to candidates with appropriate skill sets. 

• Closing date for applications is Friday, 29 May 2026 at 16h30. No late applications will be accepted. 

 

Enquiries: Ms Dineo Lemao at dineo.lemao@sahpra.org.za