SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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Please note that this is a re-advertisement, those who previously applied do not need to reapply. 
 
MANAGER: BIOLOGICAL MEDICINES 
(PHARMACEUTICAL EVALUATION MANAGEMENT) 
SALARY: LEVEL 12 (R 1 108 280 – R 1 176 293) per annum (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 39/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Matric certificate and a Bachelor of Pharmacy degree and NQF level 8 as recognised by the South African Qualifications Authority (SAQA) and a Master’s degree in pharmacy at NQF level 9. A post-graduate qualification in management would be advantageous. Proof of current registration with the South African Pharmacy Council (SAPC). A valid driver’s licence is required. 
 
EXPERIENCE ● A minimum of ten (10) years’ relevant experience in the medicines regulatory field in evaluating safety and efficacy for biological medicines, including product information and patient information leaflets, of which five (5) years must be at a supervisory/management level (Level 09 – 12) supporting business operations. Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations. Knowledge of database management will be an added advantage. 
 
COMPETENCIES, KNOWLEDGE, AND SKILLS: * Knowledge of and experience with relevant national legislation, international standards, and best practices, e.g., IMDRF, WHO, AMDF, GHWP. * Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions. * Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines. * Knowledge of technical aspects for the evaluation of quality, safety, and efficacy of medicines. Leadership skills. * Preparation and management of strategic plans, business plans, and budgeting. * Performance measurement skills. * Diversity management. * Time management. * Technical and scientific aspects of medicine regulation. * Self-motivated and able to work independently. * Computer literacy and a sound working knowledge of computer software packages. * Ability to manage a variety of cross-functional team members. * Competent in problem-solving and team building. * Information evaluation. * Decision making. * Objectivity. * Resilience. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Ethical behaviour. * Planning and organising skills. * Interpersonal skills. * Assertiveness. 
 
DUTIES: Provide regulatory strategic direction and management of activities of the Biological Medicines Unit, including risk management and audit. 

• Manage the operations of the Biological Medicines Unit concerning the processes, inputs, targets, outputs, and resourcing requirements to ensure effective operation within the unit. 
• Manage the development of regulations, regulatory processes, and guidelines within the Biological Medicines Unit to ensure efficiency, considering best practice and guidelines. 
• Perform quality assurance of processes and outputs to ensure compliance with legislative and regulatory requirements.
• Planning and coordination of the work of staff members. 
• Interpret the organisational strategy and develop a comprehensive operational strategy for the business unit that aligns with organisational goals and objectives. 
• Development and implementation of the Annual Performance Plan (APP) as per the approved strategic plan. 
• Continuous monitoring and effective compliance implementation of the unit-specific APP as per the approved plan. 
• Compilation of statistics of the Unit to compile reports for monthly, quarterly, and annual presentations. 
• Supervision of the technical and administrative work of the Unit. 
• Supervision of assessment and authorisation of registered and unregistered Biological Medicines. 

 
Supporting the work of the SAHPRA and its Advisory Committees: 

• Providing administrative and technical support to SAHPRA on the registration and amendments of biological meetings. 
• Implementation of experts and SAHPRA resolutions.
• Overseeing the recording of committee recommendations and technical discussions. 
• Overseeing document preparation for expert meetings. 

 
Management of evaluation and assessment of registration and amendments of biological medicines: 

• Peer reviewing/evaluation and assessment of applications for the amendment of the quality and clinical aspects of registered biological medicines. 
• Assessment and evaluation of applications for the registration of biological medicines (new active agents and follow-ons). 
• Peer reviewing/evaluation of quality and clinical aspects of applicant responses to committee recommendations. 
• Screening and allocation of applications to internal and external technical reviewers. 
• Referring to other international guidelines from countries, SAHPRA aligns itself with EMEA, FDA, TGA, and others, including WHO. 
• Research on regulatory sciences and medicinal development registration. 

 
Development/Update of technical guidelines and maintenance of policy, managing risk and audit queries: 

• Development of SOPs, regulations, and guidelines for registration of biological medicines and their updating. 
• Drafting of policy documents and maintenance of policy and ensuring compliance by the applicants. 
• Ensure that SAHPRA attains and maintains global best practice. 

 
Conduct consultation meetings: 

• Conduct consultation meetings with representatives from the biological medicines industry to advise on administrative and technical issues. 
• Handling/responding to enquiries and complaints from clients. 
• Responsiveness to external inquiries by industry and other departments in SAHPRA and other external stakeholders. 
• Industry engagements, other regulatory forums, regionally and internationally. 

 
Lot Release of Vaccines: 

• Overseeing of vaccines and biological medicines’ Lot Release. 
• Chair or facilitate the monthly meeting. 
• Initiate any engagement with SANCL informed by regulatory needs and requirements for vaccines. 
• Confirms and compiles the received Lot Release documents for further handling by the finance department. 

 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested 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, and copies of required qualifications (including matric). 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 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 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 21 November 2025 at 16:00. 

 
 
 
 
 
 
 

​INSPECTOR: GOOD MANUFACTURING PRACTICE (GMP) X 2
(FIXED TERM CONTRACT: UNTIL 30 MARCH 2028)
SALARY: R738 611.00 – R937 285.00 PER ANNUM (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained post qualification and community service in line with governing frameworks
Ref No.: SAHPRA 47/2025
CENTRE: Pretoria
 
REQUIREMENTS: 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 SAQA or Honours degree in Chemistry/Engineering/Biochemistry/Biology/Microbiology or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in relevant pharmaceutical regulatory or GMP environment. 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 NQF or Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment. Grade 2: Four-year Bachelor of Pharmacy degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and a minimum of three (3) years of experience in a pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment or an Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA, plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
 
COMPETENCIES, KNOWLEDGE AND SKILLS: *Comprehensive and sound knowledge of all relevant legislation, protocols, regulations, and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and 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. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. *At SAHPRA, we adhere to our core values: Ubuntu. Responsiveness. Integrity. Transparency. Efficiency. Excellence.
 
DUTIES: Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform pre- and post-registration inspections on information submitted in a medicine application dossier. Perform a once-off evaluation on information submitted by HCR (Applicants). Work closely across inspection teams, SAHPRA departments, and external regulators to ensure inspection activities are planned and communicated effectively. Evaluate Standard Operating Procedures (SOPs) of the Inspectorate for compliance with GMP/GWP guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled appropriately. Prepare reports for SAHPRA and relevant Advisory Committees and the Finance Unit. Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate Unit. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues. To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence are sufficiently maintained for audit purposes.
 
 
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). 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 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 shortlisted 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: 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 21 November 2025 at 16:00.

​ADMIN SCREENER: MEDICAL DEVICES LICENSING 
Ref No.: SAHPRA 46/2025 
SALARY: R 309, 253.00 – R 328 223.00 per annum (TOTAL COST TO COMPANY) 
 
REQUIREMENTS: Matric certificate and a post-matric qualification in Business Administration or similar. 
 
EXPERIENCE: 1-2 years of administrative experience in a regulated environment, a National Diploma will be an added advantage. 
 
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: *Thorough knowledge and understanding of sound administrative and reporting requirements *Ability to maintain a high level of accuracy in preparing and entering information and attention to detail *Report writing *Excellent interpersonal skills and communication skills (written and verbal) *Critical thinking and the ability to exercise good judgement and solve problems quickly and effectively. *Computer skills *Time Management skills *Problemsolving skills *Client orientation and customer focus *Ability to maintain high levels of confidentiality * Professionalism* Honesty and Integrity * Record keeping skills 
 
DUTIES
Screening and capturing of applications on the tracker • Communicate with applicants regarding outstanding information or documents • Making follow-ups on open applications and observation letters • Administrative support to Senior Administrative Officer • Printing and facilitation of collection of printed licences • Collection of Licence and Retention fees • Uploading PoE's in the internal audit folder for monthly reporting • Submission of statistics • Office Management. 
 
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, and copies of required qualifications (including matric). 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 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, 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/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 18 November 2025 at 16:00.

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