SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION (X2 POSTS) 
(PHARMACEUTICAL EVALUATION MANAGEMENT) 
(CONTRACT POSITION) 
SALARY: R700 105 – R888 422 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 36/2025 
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. Valid driver’s licence 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 a sound working knowledge of computer software packages. *Technical and scientific aspects of medicine regulation. *Evaluation guidelines as prescribed by the relevant regulatory authorities. *Planning and organisational skills. *Leadership skills. *Co-ordination skills. *Written and verbal communication skills. *Diversity management. *Time management. *Good telephone etiquette. *Supervisory skills. 
 
DUTIES: ● Evaluation of new applications and peer reviewing of new applications: *Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. *Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer review primary report(s) compiled by other reviewers. *Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. *Prepare query letters to applicants. *Prepare a basis of approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
● Evaluate applicant responses for registration/approval of medicines: *Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. *Following the peer-review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. *Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. *Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. *Prepare query letters to applicants. *Prepare a basis for approval or rejection. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
●Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: *Generate technical screening evaluation reports for each application and submit for peer-review. *Following the peer-review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening reports compiled by other reviewers. *Prepare screening query/screening rejection letters to applicants. *Provide quality assurance of reports and facilitate resolutions on technical matters. 
● Develop and update guidelines, SOPs and templates: *Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. *Provide training on guidelines, SOPs and templates. *Create new guidelines, SOPs and templates where relevant. *Provide regular work plans and output to the unit manager (qualitative and quantitative reports). *Perform any other related duty as requested by the manager/senior manager. 
● Form part of technical working groups or special projects and provide support to the unit as well as to advisory committees: *Participate in special projects 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). 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: 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 01 September 2025 at 16:00.

​TECHNICAL OFFICER: MEDICAL DEVICES COMPLIANCE (GRADE 1) 
(CONTRACT POSITION) 
Ref No.: SAHPRA 37/2025 
SALARY: R 700 105.00 – R743 070.00 per annum (TOTAL COST TO COMPANY) 
 
REQUIREMENTS: Matric certificate plus a Natural/ Medical Sciences/Clinical engineering/Pharmacy degree (NQF level 8). Registration with the relevant professional body. A postgraduate qualification will be an added advantage. 
 
EXPERIENCE: ● Minimum three (3) years’ experience, of which two (2) years must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices licencing legislative requirements. 
 
CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: Comprehensive knowledge and understanding of relevant legislation, the Medicine and Related Substances Act 101 of 1965, Regulations relating to Medical Devices and IVDs. Computer literacy and MS Windows computer skills, Excel and database applications. Good report writing and presentation skills. Good planning and organisational skills. Good verbal and written communication skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Pay attention to detail and information evaluation. Ethical behaviour and adherence to the SAHPRA Code of Conduct. At SAHPRA, we adhere to our core values: ubuntu, responsiveness, integrity, transparency, efficiency, collaboration, and excellence. ‘
 
DUTIES:

• Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees for compliance-related matters. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international provisions of the Medicines Act and other related Health Acts regarding medical devices and IVDs. Develop and review guidelines and standard operating procedures for Medical Devices Licensing. Proactively audit processes, practices, guidelines, and standard operating procedures for Medical Devices Licensing. Acts as contact person and liaison between Regulatory Compliance, QMS, and Medical Devices Licensing. 
• Facilitate training of Medical Devices Licensing staff on matters related to any legal changes and updates to compliance guidelines. Investigate complaints from Regulatory Compliance for any transgressions against the Medicines Act and other related Health Acts regarding medical devices and IVDs. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical devices and IVDs. Investigate and attend to industry/applicants’ queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer-reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit a weekly work plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise 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). 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 South African Qualifications Authority. 
• 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 September 2025 at 16:00.