SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials, medical devices, and related matters in the public interest.
 
SENIOR MANAGER: INSPECTORATE AND REGULATORY COMPLIANCE
Salary Level 14: R1 477 061 – R1 567 715 (all-inclusive total cost to company package)
Ref No.: SAHPRA 25/2025 (5-Year Contract)
Centre: PRETORIA
 
REQUIREMENTS: Matric certificate, Pharmacy degree/Registration as a Pharmacist with the South African Pharmacy Council (SAPC). Post-graduate qualification in Pharmaceutical or Scientific Master’s degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA). A management qualification (MBA/MBL/MAP) or similar qualification will be an added advantage. A valid driver’s licence is also required.
 
EXPERIENCE: A least 10 years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a management level (level 12 – 13) supporting business operations. Two (2) years at senior management level (level 13 – 14) will be an added advantage. Extensive knowledge and application of the Medicines & Related Substances Act (Act 101 of 1965) and its Regulations, Hazardous Substances Act 1973, National Health Act 2003, and working knowledge of the Criminal Procedure Act.
*Extensive knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Wholesaling Practice (GWP), Good Clinical Practice (GCP), Good Vigilance Practice (GVP) and Good Distribution Practice (GDP).
 
REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS AND ABILITIES)
Good understanding of the pharmaceutical industry in South Africa is required. * Detailed knowledge of various international standards and norms on the quality aspects of medicines. * Good understanding of concepts of quality management systems. * Knowledge of complaint management system. * Knowledge of various pharmaceutical marketing codes. * Knowledge of budgeting and financial management system. * Sound knowledge of medicine registration concerning safety, quality and efficacy of medicines. * Familiarity with ICH and WHO technical guidelines required. * Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of 1999) (PFMA) and its regulations, the Labour Regulations Act, 1995 (Act 66 of 1995) and the Employment Equity Act, 1998 (Act 55 of 1998). * Exposure to the evaluation of applications for registration of new chemical entities and generic applications will serve as an advantage. * Good understanding of Post-Marketing Surveillance. * General management, 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.
 
DUTIES: Develop and coordinate systems for management of all operations of the Regulatory Compliance and Inspectorate Programme. Develop a strategy, an annual performance plan, operational plans and budget for the program aligned with organisational needs and ensuring the most effective utilisation of resources.
• 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.
• Prepare monthly, quarterly and annual reports for work done within the Programme including monitoring of the timelines.
• Directs the enforcing of relevant legislation by overseeing the monitoring and managing the importation and use of narcotic drugs; the legal handling, product recalls, sale and advertisement of medicines, the investigation of alleged counterfeiting of medicines, the execution of inspections (GMP, GCP, GWP, GLP, GVP and GDP).
• Oversees preparation and endorses reports to be submitted to relevant advisory committee for their information, discussion, review and/or recommendation in accordance with prescribed legal requirements and standard operating procedures of SAHPRA.
• Oversees the effective, timeous communication and consulting thereon regarding issues relating to inspections, regulatory compliance and licensing in order to guide public health and other authorities on appropriate policies and interventions.
• Oversees the development, implementation and maintenance of regulations, guidelines, policies and procedures pertaining to regulatory compliance, inspections, licensing and laboratory services to ensure alignment with international and national protocols, legislations and other legal requirements.
• Liaises with representatives from industry and international regulators, law enforcement agencies and other relevant stakeholders to ensure appropriate and correct information and establishment of productive and relevant relationships.
• Ensure active and meaningful participation by South African regulatory functions in the global arena.
• Oversees compliance to service level agreements with outsourced support services such as laboratories to ensure achievement of agreed quality and delivery standards.
• Train and manage managers reporting to this role to ensure they have the skills required by the organisation and are able to achieve their performance objectives. Ensure that a high level of integrity is maintained by staff members by promotion of high ethical conduct and maintaining high-performance standards.
 General financial budgeting, human resources and performance management. Perform such other functions as the Chief Regulatory Officer or the Chief Executive Officer may duly allocate or delegate from time to time.
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
 Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources.
 Should you 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 South Africa (1996), the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated.
 SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
 SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
 Applications should be submitted to Itumeleng.Mosenyi@sahpra.org.za
 For enquiries: please contact Mr Itumeleng 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 08 August 2025 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 provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest. 
 
MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION 
(PHARMACEUTICAL EVALUATION MANAGEMENT) 
SALARY: R700 105.00 – R888 422.00 PER ANNUM (TOTAL COST TO COMPANY) 
(Grade 1 – Grade 2) Market-related salary will be determined by the years of experience obtained post-qualification and community service in line with governing frameworks. 
Ref No.: SAHPRA 33/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) or an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA. A relevant Master’s qualification at NQF Level 9 as recognised by SAQA will be an added advantage. A valid driver’s licence is required. 
 
EXPERIENCE
Grade 1: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC, plus a minimum of three (3) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years’ regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
Grade 2: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: *Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines. *Knowledge of the technical aspects for the evaluation of the quality and efficacy (bioequivalence) of medicines. *Computer literacy and sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Co-ordination skills. *Written and verbal communication skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills. 
 
DUTIES: ● Evaluation of new applications and peer reviewing of new applications: *Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with the required template and adopted regulatory/scientific standards and submit for peer review. *Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer review primary report(s) compiled by other reviewers. *Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. *Prepare query letters for applicants. *Prepare a basis for approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
● Evaluate applicant responses for registration/approval of medicines: *Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. *Following the peer-review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. *Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. *Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. *Prepare query letters to applicants. *Prepare a basis for approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
●Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: *Generate technical screening evaluation reports for each application and submit for peer review. *Following the peer-review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening reports compiled by other reviewers. *Prepare screening query/screening rejection letters to applicants. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
● Develop and update guidelines, SOPs and templates: *Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. *Provide training on guidelines, SOPs and templates. *Create new guidelines, SOPs and templates where relevant. *Provide regular work plans and output to the unit manager (qualitative and quantitative report). *Perform any other related duty as requested by the manager/senior manager. 
● Form part of technical working groups or special projects and also provide support to the unit as well as to advisory committees: *Participate in special projects and registration groups. *Lead and manage assessments peer-review and discussion working groups, where relevant. *Compile discussion documents and reports. *Provide regular training to new internal medicine registration officers (MROs) and external evaluators. *Take comprehensive notes of discussions of relevant discussions. *Prepare documents for the SAHPRA management/RC meetings. 
● Risk Management and Audit: *Adhere to SOPs and guidelines. *Create and maintain databases. *Use the most current templates and guidelines. *Provide and attend relevant training as may be necessary. *Align with Quality Management System requirements. *Align with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards. 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

• Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview, following communication from Human Resources. 
• Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA. 
• Incomplete applications or applications without the aforementioned documents or information will not be considered. 
• No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned. 
• Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful. 
• Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 
• Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 
• SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated. 
• SAHPRA reserves the right not to make any appointment(s) to the advertised post(s). 
• SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes. 
• Applications should be submitted through the SAHPRA Website Online Portal: 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 01 August 2025 at 16:00.