Job Description

Closing Date 2025/10/10
Reference Number CAP250925-3
Job Title Regulatory Manager
Site CAPRISA Head Office (DDMRI)
Job Type Classification 2 Year Fixed Term Contract - renewable
Location - Town / City Durban
Location - Province KwaZulu-Natal
Location - Country South Africa

CAPRISA is an award-winning global research organisation located on the campus of the Nelson R Mandela School of Medicine in Durban, South Africa and undertakes research in HIV, TB and Covid at four clinical research sites in KwaZulu-Natal. CAPRISA's goal is to undertake globally relevant and locally responsive research that contributes to understanding HIV Vaccines and Pathogenesis, Prevention and Epidemiology, the links between Tuberculosis and AIDS treatment and Covid-19. CAPRISA is a UNAIDS Collaborating Centre for HIV Research and Policy and is recognised as a DSI-NRF Centre of Excellence in HIV Prevention and hosts the SAMRC HIV-TB Pathogenesis and Treatment Research Unit.
The successful incumbent will join the CAPRISA Gates Foundation Vaginal Microbiome Clinical Trials Unit (VM-CTU) and will be based at the CAPRISA Headquarters in Durban.
Minimum Requirements

• Master's Degree in Science, Medicine, Microbiology, Public Health or associated allied health professions.
• At least 2-3 years demonstrable experience in preparing Regulatory (SAHPRA) and Ethics submissions, report writing, including submitting and tracking of routine and expedited safety reports.
• Previous clinical trial conduct experience.
• Previous experience with Drug Safety Update Reporting (DSUR) for SAHPRA.
• Previous experience with SANCTR, PACTR and ClinTrials.gov submissions.
• Previous demonstrable experience with Trial Master File (TMF) and Investigator Site File (ISF) set up and maintenance.
• ICH (R3) and SA GCP certification.
• Computer literate and advanced skills with MS Office and MS Project.
• Previous eTMF or eISF software experience would be advantageous.

Personal Qualities and Competencies

• Strong attention to detail with a commitment to accuracy and data integrity.
• Excellent organizational and time management skills with the ability to manage multiple priorities under tight timelines.
• Effective communication and interpersonal skills to foster collaborative relationships across multidisciplinary teams.
• Ability to work proactively and independently, while also being a strong team player.
• Analytical and problem-solving skills with a practical, solutions-oriented approach.
• High level of integrity, discretion, and professionalism in handling confidential information.
• Adaptability and resilience in a fast-paced, dynamic early-phase research environment.

Key Responsibilities

• Develop and maintain Standard Operating Procedures relevant to the portfolio.
• Co-ordinate the regulatory obligations (initial submissions, amendments, re-certification, reports, ad-hoc correspondence, trial registry registration and updates) of the VM-CTU for all supported trials - estimated 5 trials per annum.
• Work in conjunction with trial study coordinators to obtain necessary documents for submission.
• Coordinate regulatory activities with VM-CTU project manager and protocol development specialist to meet the regulatory submission deadlines.
• Work with individual trial PIs for development, regulatory submissions, distribution of clarification memos, letters of amendment and maintenance of read acknowledgements.
• Liaise with regulatory and ethics authorities for administrative matters.
• Maintain eTMF for each clinical trial supported by the VM-CTU including but not limited to CV updates and GCP training certification tracking.
• Maintain Standard Operating Procedures Masterfile for the VM-CTU.
• Oversee the development of the Trial Monitoring Plans for each trial in conjunction with the trial Clinical Research Associate and track monitoring reports and resolution of findings with the site study coordinators.
• Report writing in accordance with funder, sponsor and regulatory body requirements.

Skills Required