Regulatory Officer

• 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 for the post: 

• 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

Thefollowingwould beadvantageous:

• 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

The 2026 annual cost of employment, including benefits, is between R448 889 and R528 105

Closing date: 10 November 2026