SAHPRA Vacancies

To apply, click on the link at the end of the posts and all the best with your applications.

INSPECTOR: GOOD MANUFACTURING PRACTICE (GMP) X 2

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.

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.

MANAGER: BIOLOGICAL MEDICINES

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.

Please note that this is a readvertisement, 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 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:
  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.

We wish you all the best with your applications