SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES - 23 JULY 2026

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.

MEDICINE REGISTRATION OFFICER: CLINICAL PREREGISTRATION EVALUATION (1-YEAR CONTRACT)

SALARY: R 562 800.00 – R 681 300.00 PER ANNUM (TOTAL COST TO COMPANY)

Ref No.: SAHPRA 24 of 2026/27

CENTRE: PRETORIA

REQUIREMENTS: A matric certificate and a 4-year degree in Pharmacy or a 4-year degree in Health-Sciences-related field (NQF Level 8) as recognised by the South African Qualification Framework (SAQA). Registration with the South African Pharmacy Council (SAPC) where applicable is required. A relevant NQF level 9 qualification in Health Sciences will be an added advantage.

EXPERIENCE: A minimum of three (3) years' relevant post-internship experience.

COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations, concerning the regulation of medicines with respect to quality, safety, and efficacy. Knowledge of the technical aspects and evaluation processes relating to the quality efficacy and bioequivalence of medicines. Comprehensive knowledge and understanding of relevant legislation, regulatory guidelines, protocols, standard operating procedures (SOPs), and work instructions applicable to SAHPRA’s regulatory environment.

· Possess good planning, organizational and interpersonal skills.

· Self-motivated and can work without supervision.

· Have good communication skills (written, and verbal) and ability to negotiate, solve conflicts and prepare presentations.

· Ability to come with innovations, initiate, and demonstrate assertive and leadership qualities.

· Be dedicated and pay attention to details.

· Ethical and maintain high level of integrity.

· Must be willing to travel and work beyond normal working hours.

· Must have good customer service.

DUTIES: Evaluation of new applications and peer-reviewing of new applications/variations:

· Must produce evaluation reports for new applications and submit them for peer review as well as ensuring compliance with prescribed templates and existing regulatory /scientific standards (depending on the type of application, i.e., Full/partial reviews Q-BE and Reliance.

· Evaluate Type I and II applications for clinical or quality variation.

· Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants using prescribed templates (Full/partial reviews Q-BE and reliance).

· Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards (Full/partial reviews Q-BE and reliance)

· Evaluate PI/PIL applications (new applications and responses).

· Prepare query or feedback to the applicant (approval or rejection letter).

Evaluate applicant responses for registration/approval of medicines:

· Produce another evaluation report for application reviews.

· Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants, where applicable.

· Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards.

Develop and update guidelines, SOPs, and templates:

· Review existing guidelines, Standard Operating Procedures (SOPs) and templates and update them when necessary.

· Train new Medicine Registration Officers (MROs) and external evaluators, and attend workshops about latest guidelines, SOPs and templates.

· Develop new guidelines, SOPs, and templates where applicable.

· Submit work plans and targets to the Business Unit Manager (qualitative and quantities report).

· Perform other duties that a senior manager or Business Unit manager may assign to you.

Participate in technical working groups or special projects and provide support to the Business Unit as well as to the Advisory Committees:

· Prepare report for the internal working groups and/or advisory committee. Present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines.

· Provide quality assurance to reports and facilitate resolutions on technical matters.

· Align with ICH, WHO, IPRP, international standards, SAHPRA QMS requirements and use the most current SAHPRA templates and guidelines.

· Execute recommendations from the advisory committee timeously.

Provide technical advice and information to all stakeholders (internally and externally):

· Attend to queries from various stakeholders.

· Provide technical advice and information to all stakeholders.

· Attend to queries from the Manager, Senior Manager, other Programmes, the legal unit and the Chief Regulatory Officer’s office.

Technical screening of applications for the registration of medicines:

· Produce evaluation reports for technical screening of applications and submit them for review.

· Comply with the report review process and amend technical screening report to generate queries for the applicant using correct templates.

· Review technical screening reports compiled and reviewed by other colleagues or peers.

· Prepare screening feedback to the applicant (Rejection or approval letter).

· Provide quality assurance to reports and facilitate solutions to technical matters.

HOW TO APPLY (INSTRUCTIONS TO APPLICANTS):

· Interested candidates who meet the above-mentioned requirements should submit their application, clearly stating the position title and post reference number, together a signed cover letter, detailed Curriculum Vitae (CV) containing the names and email addresses of three (3) referees, copies of qualifications (including matric) and a copy 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.

· 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), males (all races) and females (Coloured and White) will be given preference.

· SAHPRA reserves the right not to make any appointment to the advertised posts.

· 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 Bafedile Rakgotho, via email at bafedile.rakgotho@sahpra.org.za.

NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.

The closing date is 05 August 2026 at 16:00.

MEDICINE REGISTRATION OFFICER: CLINICAL TRIALS

SALARY: R 562 800.00 – R 681 300.00 PER ANNUM (TOTAL COST TO COMPANY)

Ref No.: SAHPRA 25 of 2026/27

CENTRE: PRETORIA

REQUIREMENTS: A matric certificate and 4-year degree in pharmacy at NQF level 8 as recognised by the South African Qualifications Authority (SAQA). Registration with the South African Pharmacy Council. A relevant master’s degree in pharmacy will be an added advantage.

EXPERIENCE: A minimum of three (3) years' relevant post-internship experience.

COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and understanding of the use of data capturing.

· Demonstrate strong administrative, planning and organising skills.

· Must have good communication skills (verbal and written).

· Must be computer literate (MS Office Suite).

· Pay attention to details.

· Ability to work under pressure and with no supervision.

· Must be able to work in a team, resilient, assertive, innovative and meet deadlines.

· Willingness to work beyond normal working hours where applicable.

DUTIES: Technical review of clinical trial applications and provide recommendations for approval/rejection of clinical trial applications:

· Screen new applications for clinical trials to ensure adherence to SAHPRA requirements.

· Conduct technical evaluations of applications for clinical trials.

· Recommend applications for review to the Clinical Trials Expert Committee.

· Review responses from applicants and recommend a decision (approval or rejection) of clinical trial applications.

· Communicate the decision (approval or non-approval) or queries to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting (Finance, performance).

· Manage application cycles for submission of clinical trials.

Technical Review of applications to conduct Bioequivalence studies and provide recommendations for approval/rejection of clinical trial applications:

· Technical screening of new Bioequivalence studies to ensure adherence to SAHPRA requirements. Technical Review of Bioequivalence studies applications.

· Recommend applications to the Clinical Trials Expert Committee where applicable.

· Review applicant responses and recommend for approval or rejection of Bioequivalence studies.

· Communicate the decision (approval or non-approval to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting. Manage submission of Bioequivalence from receipt to finalisation.

Provide technical support to appropriate Expert Committee/s and SAHPRA in general:

· Allocate clinical trials to the external evaluators in accordance with their expert areas.

· Co-ordinate clinical trials applications and monitor progress of review (follow up with external evaluators).

· Liaise with advisory committee members and external reviewers.

· Prepare agenda and documentation to present at the Clinical Trials Expert Committee.

· Support the proceedings of the Clinical Trial Committee meetings, including the expert consultation meetings.

· Prepare minutes and recommendations following the meeting of the Clinical trials expert committee.

· Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.

Review safety information, progress reports and any other clinical trials correspondence:

· Review Serious Adverse Events (SAE) reports, progress reports and other safety reports during the Conduct of Clinical Trials and Bioequivalence studies.

· Validate the SAE report on the system after review.

· Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings.

· Set up systems to implement the process of SAE reporting.

· Advise on improvement of system or any other processes in the Business Unit.

· Liaise with advisory committee members of the Clinical Trials Safety Monitoring Committee.

· Prepare agenda and documentation to present at the Clinical Trials Safety Monitoring Committee.

· Support the proceeding of the Clinical Trial Committee meetings.

· Prepare minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee.

· Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings.

Review applications for protocol amendments for clinical trials applications and Bioequivalence studies:

· Screening and technical review of applications for protocol amendments in line with set timelines in annual operations plan.

· Allocation of clinical trials protocol amendment to the external evaluators in accordance with expert areas.

· Advise on improvement of system or any other processes in the Business Unit.

· Check the status of all applications received to monitor timeline in line with Annual Performance Plan (APP) or Annual Operational Plan (AOP).

· Attend and respond to queries and complaints related to applications from external stakeholders in time.

· Update spreadsheet on regular basis.

· Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.

Review applications for additional investigators and sites for clinical trials applications and Bioequivalence studies:

· Review investigators, change in investigators/Principal investigators or additional sites in line with the set timelines.

· Check the status of all applications received to monitor timeline in line with the Annual Performance Plan or Annual Operational Plan.

· Attend and respond to queries and complaints related to applications from external stakeholders in time. Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting.

Develop policies, guidelines as well as standard operating procedures for conducting clinical trial:

· Draft and review existing policies and lead preparation of policy document.

· Develop and review existing Standard Operating Procedures (SOP) and ensure that there are SOPs in place for services offered by SAHPRA.

· Ensures the Business Unit complies with the approved Standard Operating Procedures.

Manage and perform performance assessment of administrative staff and attend to queries addressed to the Clinical Trials Unit:

· Manage administration staff and ensure that the Business Unit meet the deadlines for queries.

· Conduct performance assessment for administration staff in the Business Unit.

Advise and attend to pharmaceutical industry / applicant’s queries or other members of the Public:

· Investigate and advise pharmaceutical industry / applicant’s queries or other members of the public.

· Manage resolution of the queries in your area of work.

· Advise or make recommendations to the Inspectorate and Regulatory Compliance Unit.

· Represent SAHPRA at the local and international events

· Arrange meetings with industry task groups and attend external stakeholder meetings.

Manage the associated risks and audit queries:

· Attend and support internal and external audit meeting and attending to audit queries.

· Manage and keep records of clinical trials.