SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

​MANAGER: BIOLOGICAL MEDICINES 
(PHARMACEUTICAL EVALUATION MANAGEMENT) 
SALARY: LEVEL 12 (R 1 050 503 – R 1 237 437) per annum (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 39/2025 
CENTRE: Pretoria 
 
REQUIREMENTS: ● Matric certificate and a Master’s degree in Pharmacy at NQF level 9 as recognised by the South African Qualifications Authority (SAQA) or a Master’s degree in a related Health Science such as Biotechnology, Vaccinology or haematology. A post-graduate qualification in management would be advantageous. Proof of current registration with the South African Pharmacy Council (SAPC) as applicable. A valid driver’s licence is required. 
 
EXPERIENCE ● A minimum of eight (8) year’s relevant experience in the medicines regulatory field in compiling/evaluating safety and efficacy for biological medicines, including product information and patient information leaflets, of which three (3) years must be at a supervisory/management level 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., ICH, WHO. * 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. Familiar with Vaccine Lot release requirements. * 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 expert advisory committee 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. 
• Making reference to other international guidelines from such as ICH and countries that SAHPRA aligns itself with e.g EMEA, USFDA, Swissmedic, 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 meetings related to Lot Release function. 
• 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 25 September 2025 at 16:00.