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. 

 

 

 

TECHNICAL SCREENER: HEALTH PRODUCTS AUTHORISATIONS 

TYPE OF CONTRACT: PERMANENT

SALARY LEVEL 08: R563 996.00 – R598 626.00 PER ANNUM (TOTAL COST TO COMPANY) 

Ref No.: SAHPRA 08 of 2026/27 

CENTRE: PRETORIA 

 

REQUIREMENTS: Matric certificate and appropriate 3-year Bachelor of Science Degree in Chemistry, Biochemistry or Pharmaceutical Sciences at NQF level 7 as recognised by South African Qualifications Authority (SAQA). Appropriate 4-year degree in Chemistry/Pharmacology or Bachelor of Pharmacy at NQF level 8 as recognised by SAQA will be an advantage. Registration with a statutory council if applicable.

 

EXPERIENCE: Three (3) years of relevant regulatory experience. Experience in product review or assessments will be an added advantage. 

 

COMPETENCIES:

Knowledge and Good Understanding: Theoretical knowledge of technical aspects for the evaluation of medicines across all fields as stipulated in the Medicines and Related Substances Act No. 101 of 1965. Safety and efficacy. Quality and bioequivalence. Naming and scheduling. Good Manufacturing Practice. Knowledge of the regulatory environment. Good Clinical Practice. Pharmacovigilance. 

 

Skills: Comfortable working with computers and computer software packages. Display a strong academic background. Good and effective communication skills (written and verbal). Planning and coordination skills. Conflict management. Critical thinking and problem-solving skills. Self- Management. 

 

Attributes: Ability to remain self-motivated and work independently. Positive attitude. Team player. Ability to work precisely and efficiently. Ethical behaviour and adherence to the SAHPRA Code of Conduct. Flexible. Deadline driven. Honest. Ability to prioritise and display excellent time management skills. Ability to work under pressure. Ability to tolerate stress. Responsiveness. Relationship management. 

 

DUTIES:

Technical Screening of Medicines Applications: Assess each module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines. Generate a validation report and submit to the portfolio coordinator for peer review or sign-off. Generate a list of queries to the applicant for applications that do not comply with applicable guidelines. Complete and sign a technical screening outcome report within target timelines. Communicate the technical screening outcome to the Evaluator Co-ordinator. Conduct peer review of technical screening reports done by other technical screeners. Save the relevant reports in the folder structure for the specific application. Conduct technical screening, assign classifications, and review pathways for new medicines registration and/ or variations when backup support is required by the business. Timely assessment and identification of medicine safety issues or signals stemming from pharmacovigilance recommendations. Source reliance reports from the relevant Recognised Regulatory Authorities (RRA) through the focal person. Identify and confirm applications for internal reliance and capture on the screening outcome report and on the Tracker. 

Technical Screening of Query Responses: Assess each module of the application against the relevant technical screening form to ensure they are appropriate in terms of format and content as defined by the relevant guidelines. Generate a validation report and submit to the portfolio coordinator for peer review/ sign-off. Generate a list of queries to the applicant for query responses that do not comply with applicable guidelines. Complete and sign a technical screening outcome report within target timelines. Communicate the technical screening outcome to the Evaluator Co-ordinator. Conduct peer review of technical screening reports done by other technical screeners. Save the relevant reports in the folder structure for the specific application. 

Track and convey statuses to Portfolio Coordinator: Capture outcome of the screening and completion date on the Tracker or database. Provide relevant statistics and evidence for Performance Reporting monthly. Identify and report on trends for decision making. 

Management of Risk and Audit Queries: Adherence to standard operating procedures and SAHPRA guidelines. Ensuring that SOPs are maintained. Attend relevant training to support your function. Respond to queries and non-conformances raised by internal and external stakeholders. Support business units with Quality Management Systems (QMS) internal and external audits, including ISO 9001:2015 certification. 

Stakeholder Management: Liaise with Evaluator Coordinators regarding allocations of screening applications and ensure that Portfolio Coordinators are kept updated on the status of applications. 

People Management: Manage own time and deliverables to ensure that they contribute to the team’s outputs. Completes validation reports and query letters. 

Finance: Apply the organisation policies and comply with procurement and finance procedures. 

 

 

 

 

 

INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): 

·       Interested candidates who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric) and Identity Document. 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 Unit. 

·       Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from 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), the Employment Equity Act, 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) and men are encouraged to apply. 

·       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: SAHPRA website (https://www.sahpra.org.za/vacancies) / Portal Link (https://apply.sahpra.org.za:6006/).

·       For enquiries: Please contact Ms Setlola Molepo, via email at setlola.molepo@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 

·       The closing date is 22 May 2025 at 16H00.