Regulatory Officer

REGULATORY OFFICER (Payclass 8; T1 contract for 12 months) INSTITUTE OF INFECTIOUS DISEASE AND MOLECULAR MEDICINE (IDM) FACULTY OF HEALTH SCIENCES The Centre for Infectious Diseases Research in Africa (CIDRI-Africa) based at the Institute of Infectious Disease and Molecular Medicine (IDM) in the Faculty of Health Sciences invites applications from suitably experienced candidates for a 12-month contract position as a Regulatory Officer based at the CIDRI Africa offices UCT with periodic visits to Site B Khayelitsha.

The purpose of this position is to be responsible for ensuring that clinical trials adhere to regulatory guidelines, which are in place to protect the rights and welfare of study participants. The position holder will work closely with researchers, sponsors, and regulatory agencies to ensure that all necessary approvals and documentation are in place before a clinical trial can begin.

Requirements

National Diploma / NQF4 or equivalent 2 years’ experience as a regulatory officer Previous experience or knowledge of regulatory support for multi-centered international clinical trials Excellent knowledge of current regulatory requirements governing clinical trials including a practical understanding of GCP Valid GCP certificate Knowledge of health data systems and quality control processes Understanding of local and international laws, industry standards, and regulatory compliance frameworks High level of attention to detail, project management, time management and organizational skills The following would be advantageous: High competency in use of Microsoft Office applications, including Excel and Teams Ability to assimilate, analyse and present data Exceptional oral and written communication skills Ability to successfully multi-task and work in a multi-cultural team Key responsibilities include: Preparing, compiling, and submitting Clinical Trial Applications (CTA) and Investigational New Drug (IND) to health authorities (such as the FDA or SAHPRA and Institutional, review boards and Ethics Committees Acting as the primary, connection between the CIDRI Africa, RO/CRA and external regulatory bodies Monitor compliance and quality assurance Stakeholder liaison and communication with Dept of Health Proactively evaluating regulatory landscapes to advise project leadership Monitoring changes in healthcare and flag updates Amend internal Standard Operating Procedures (SOPs)when needed and advise clinical teams accordingly Ensuring safety guidelines are upheld throughout and possibly beyond the trial lifecycle Working alongside PIs and RMO teams to manage, log, and report Serious Adverse Events(SAE) and other reportable events to regulatory bodies and IRB’S within mandated timelines.

Maintaining accurate, audit-ready oversight of all essential study records Building and updating electronic regulatory study binders. Tracking investigator site files, staff training logs, professional licenses, and CV. Train clinical teams on all new systems For detailed information about this post, please view the position description at the following link: (View) The 2026 annual cost of employment, including benefits, is between R448 889 and R 528 105 To apply, please visit the UCT Careers site (For Internal Applicants) and (For External Applicants) to create a profile and submit your application.

Please complete/attach the following to your profile before submitting your application: A letter of motivation, outlining how your expertise aligns with the position's requirements A detailed Curriculum Vitae (CV). Copy of your qualifications and ID. Three referee names which must include their title and name, position details, relationship with you, their e-mail address and telephone number.

An application which does not comply with the above will be regarded as incomplete and might not be considered. Only shortlisted candidates will be contacted and maybe required to undergo competency assessments. References may be requested by UCT at any stage of the selection process. Enquiries about the application process are to be addressed to Mrs Tracy Moore at tracy.

[email protected] Please do not send or submit job applications/CVs via this e-mail. Telephone: 021 650 5405 Website: www.uct.ac.za Reference number: ID1572 Closing date: 10 November 2026