Regulatory Manager (Healthcare - 2 year FTC - Renewable)

SUMMARY:
Background:

• Our client is an award-winning global clinical research organisation in the Durban area
• They undertake research in HIV, TB and Covid

POSITION INFO:
Contract Period:  2 year Fixed Term Contract, Renewable

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

• Master’s Degree in Science, Medicine, Microbiology, Public Health or associated Allied Health Professions
• 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 experience with Trial Master File (TMF) and Investigator Site File (ISF) set up and maintenance
• ICH (R3) and SA GCP Certification
• Proficient on MS Office and MS Project
• Previous eTMF or eISF software experience advantageous

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the minimum requirements will not be considered for the respective position
• Note our clients may expire jobs at their own discretion
• AJ PERSONNEL will only respond to shortlisted candidates
• If you have not received a response within two (2) weeks from applying, your application was then unsuccessful for that specific position, however your profile remains on our system for future opportunities
• Closing Date: 10 October 2025
• Note: No CV will be accepted after the closing date