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MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION (PHARMACEUTICAL EVALUATION MANAGEMENT) (REF: SAHPRA 23 OF 2026/27)
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 monitor, evaluate, regulate, investigate, inspect, register and control medicines,
schedule substances, clinical trials and medical devices, including IVDs, and related matters in the
public interest.
MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION
(PHARMACEUTICAL EVALUATION MANAGEMENT)
(CONTRACT POSITION UNTIL 31 MARCH 2028)
SALARY: R562 800.00 – R681 300.00 PER ANNUM (TOTAL COST TO COMPANY)
REF NO.: SAHPRA 23 of 2026/27
CENTRE: PRETORIA
REQUIREMENTS: ● Applicants must have a Matric certificate and appropriate four-year Bachelor of
Pharmacy degree (NQF Level 8) or an Honours degree in related health sciences as recognised by the
South African Qualification Authority (SAQA) * Registration with the South African Pharmacy Council
(SAPC). (SAQA * A relevant master’s degree qualification at NQF Level 9 as recognised by SAQA will
be an added advantage * Valid driver’s licence required.
EXPERIENCE
- Bachelor of Pharmacy (NQF Level 8): Minimum of 2 years’ relevant post-internship experience
in pharmaceutical or related medicines regulation, or in medicines production quality assurance
outside SAHPRA; alternatively, at least 1 year of relevant experience within SAHPRA. - Honours degree in a related Health Sciences field (NQF Level 8): Minimum of 3 years’ relevant
experience in pharmaceutical or related medicines regulation, or in medicines production quality
assurance outside SAHPRA; alternately, at least 1 year of relevant experience within SAHPRA.
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.
● 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 * Develop new guidelines, SOPs and templates * Prepare and submit
regular work plans and qualitative and quantitative performance reports to the manager * Perform
any other related duty as requested by the manager/senior manager.
● Member of technical working groups or special projects and provide support to the Business Unit
as well as to advisory committees: *Participate in special projects and medicines 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/Regulatory Committee
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
HOW TO APPLY (INSTRUCTIONS TO APPLICANTS):
- Interested candidates who meet the above requirements should submit their applications,
clearly indicating the title of the position and the reference number. Applications must
include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email
addresses of three (3) referees, and certified copies of the required qualifications
(including matric). Only shortlisted candidates will be required to submit certified copies
of qualifications and other relevant documents on or before the interview date, as
communicated by 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 closing date and
time will not be considered. - Due to the anticipated high volume of applications, communication will be limited to
short-listed candidates only. Candidates 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 on a specific date,
time, and location as communicated 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 No. 108 of 1996, and the Employment Equity Act No. 55 of
1998. - SAHPRA promotes equity (race, gender, and disability) in line with the numeric targets in our
Employment Equity plan. We are committed to this when recruiting internally and
externally, with a policy to promote from within wherever possible. Preference will be given
to suitably qualified individuals from previously disadvantaged groups. - People with disabilities (should indicate their disability status), males (all races) and
females (Coloured and White) will be given preference. - SAHPRA reserves the right not to appoint any candidate to the advertised post.
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA) No.
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 30 July 2026 at 16:00.
INSPECTOR GMP (GOOD MANUFACTURING PRACTICES)
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 monitor, evaluate, regulate, investigate, inspect, register and
control medicines, schedule substances, clinical trials and medical devices, including IVDs,
and related matters in the public interest.
INSPECTOR GMP (GOOD MANUFACTURING PRACTICES)
(FIXED TERM CONTRACT: UNTIL MARCH 2028)
SALARY: R562 800.00 – R919 200.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 22 of 2026/27
CENTRE: PRETORIA
REQUIREMENTS: A 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. A relevant master’s degree in Pharmacy qualification at NQF level 9 as recognised
by SAQA will be an added advantage. Must have a valid driver’s licence.
EXPERIENCE: Minimum of five (5) years of experience in pharmaceutical industry or GMP
environment. Experience must be post community service. Knowledge of GMP regulations and
industry practice, as well as experience of undertaking GMP inspections within a regulatory
environment.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Comprehensive and sound knowledge of all relevant
legislations, protocols, regulations, and guidelines about 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 with other 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 the 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, and 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 inspectionrelated resources, and that all relevant records and evidence are sufficiently maintained for audit
purposes.
HOW TO APPLY (INSTRUCTIONS TO APPLICANTS) :
Interested candidates who meet the above requirements should submit an application clearly
indicating the title of the position and reference number. Applications must include a signed cover
letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees,
and certified copies of the required qualifications (including matric). Only shortlisted candidates
will be required to submit certified copies of qualifications and other relevant documents on or
before the interview date, as communicated by 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 (1996) and the Employment Equity Act, 55 of 1998.
SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in
our Employment Equity plan. We are committed to this when recruiting internally and externally,
with a policy to promote from within wherever possible. Preference will be given to suitably
qualified individuals from previously disadvantaged groups. Applicants with disabilities are
encouraged to apply and indicate their disability status.
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 24 July 2026 at 16:00.
MEDICINE CONTROL OFFICER: LICENSING 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 monitor, evaluate, regulate, investigate, inspect, register and
control medicines, schedule substances, clinical trials and medical devices, including IVDs,
and related matters in the public interest.
MEDICINE CONTROL OFFICER: LICENSING X 2
SALARY: R562 800.00 – R919 200.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 21 of 2026/27
CENTRE: PRETORIA
REQUIREMENTS: A Matric certificate and four-year Bachelor of Pharmacy degree at NQF level 8. A
relevant Master’s degree qualification will be an added advantage. Registration with the South African
Pharmacy Council. Must have a valid driver’s licence.
EXPERIENCE: A minimum of five (5) years of relevant experience in a pharmaceutical regulatory and/or
GxP environment, post community service.
COMPETENCIES, KNOWLEDGE AND SKILLS:
The candidate must have comprehensive knowledge and application of the Medicines and Related
Substances Act 101 of 1965, as amended, and its related Regulations.
Demonstrate knowledge of technical aspects (principles of GMP and GWP and applicable
guidelines) for evaluation of facility licence applications to manufacture and wholesale medicines
and scheduled substances.
Must have knowledge and understanding of international regulatory strengthening and
benchmarking frameworks, including the World Health Organization (WHO) Global Benchmarking
Tool (GBT) for National Regulatory Authorities.
Analytical skills, numerical reasoning, and good interpretation of written and numerical data.
Good communication skills (verbal, written, conflict management, and resolution).
Efficient, professional and excellent delivery of services.
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 in a team environment.
Good planning and organisational skills.
Ability to meet deadlines and manage multiple tasks and competing priorities.
Computer literacy (MS Office packages and database management).
Ethical behaviour and adherence to the SAHPRA Code of Conduct.
Demonstrate SAHPRA values in the execution of their duties.
DUTIES:
Technical Evaluation of pharma licence applications submitted for the granting or re-granting of
pharma licences to determine the level of compliance with the provision of the Act and its
regulations, principles of GMP and GWP and applicable guidelines.
Communicate with relevant stakeholders to assess the status of pharma licence applications and
ensure that applications are appropriately tracked.
Regularly update applicable databases and registers.
Implementation and maintenance of the QMS within Pharma Licencing Unit:
Comply with Guidelines and SOPs, review and update them within defined review timeframes as
per the SAHPRA QMS requirements.
Investigations of non-conformances, CAPAs identified and implemented as per the SAHPRA QMS
requirements.
Contribute significantly towards preparations for the WHO benchmarking assessment and reassessments and ensure the WHO Maturity Level within the Pharma Licencing Unit is maintained.
Ensure Performance and Finance Reports are accurately prepared and submitted within defined
timelines as per applicable guidelines.
Respond adequately and timeously to queries related to pharma licencing and relevant processes
and ensure advice communicated to the public is accurate and within the provisions of the Act,
Regulations and SAHPRA guidelines.
Attends stakeholders’ meetings.
HOW TO APPLY (INSTRUCTIONS TO APPLICANTS):
Interested candidates who meet the above requirements should submit an application clearly
indicating the title of the position and reference number. Applications must include a signed cover
letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees,
and certified copies of the required qualifications (including matric). Only shortlisted candidates
will be required to submit certified copies of qualifications and other relevant documents on or
before the interview date, as communicated by 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 (1996) and the Employment Equity Act, 55 of 1998.
SAHPRA intends to promote equity (race, gender, and disability) in line with the numeric targets in
our Employment Equity plan. We are committed to this when recruiting internally and externally,
with a policy to promote from within wherever possible. Preference will be given to suitably
qualified individuals from previously disadvantaged groups. Applicants with disabilities are
encouraged to apply and indicate their disability status.
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 24 July 2026 at 16:00.
We wish you all the best with your applications
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