Regulatory Officer (Clinical Trials)

About the role

The Centre for Infectious Diseases Research in Africa (CIDRI-Africa), part of the Institute of Infectious Disease and Molecular Medicine in the Faculty of Health Sciences at the University of Cape Town, is hiring a Regulatory Officer for a 12-month contract (payclass 8, T1). The post is based at the CIDRI Africa offices in Cape Town, with periodic visits to Site B Khayelitsha. Its purpose is to ensure that clinical trials follow regulatory guidelines that protect the rights and welfare of study participants, working closely with researchers, sponsors and regulatory agencies.

Key responsibilities

• Prepare, compile and submit Clinical Trial Applications (CTA) and Investigational New Drug (IND) applications to health authorities such as the FDA or SAHPRA, and to institutional review boards and ethics committees.
• Act as the main link between CIDRI Africa, the regulatory officer/CRA and external regulatory bodies.
• Monitor compliance and quality assurance, and liaise with the Department of Health.
• Evaluate regulatory landscapes proactively and advise project leadership, and flag changes in healthcare.
• Amend internal Standard Operating Procedures (SOPs) when needed and advise clinical teams.
• Ensure safety guidelines are upheld throughout, and possibly beyond, the trial lifecycle.
• Work with principal investigators and research management officers to manage, log and report Serious Adverse Events and other reportable events to regulators and IRBs within mandated timelines.
• Maintain accurate, audit-ready study records and build and update electronic regulatory study binders.
• Track investigator site files, staff training logs, professional licenses and CVs, and train clinical teams on new systems.

Required profile

• National Diploma (NQF Level 4) or equivalent.
• 2 years' experience as a regulatory officer.
• Previous experience or knowledge of regulatory support for multi-centred international clinical trials.
• Excellent knowledge of current clinical trial regulatory requirements, including a practical understanding of GCP and a valid GCP certificate.
• Knowledge of health data systems and quality control processes, and of local and international laws, industry standards and compliance frameworks.
• High attention to detail, project management, time management and organisational skills.

Required skills

• Advantageous: high competency in Microsoft Office, including Excel and Teams.
• Ability to analyse and present data, and strong oral and written communication skills.
• Ability to multi-task and work in a multi-cultural team.

The 2026 annual cost of employment, including benefits, is between R448,889 and R528,105. Applications are submitted through the UCT careers site with a letter of motivation, CV, copies of qualifications and ID, and three referees; the closing date is 10 November 2026.