SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)

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.