Regulatory Manager (TEMP - Wits RHI)

SUMMARY:
Background:

• The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges
• It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology

POSITION INFO:
Main purpose of the job:

• To manage the submissions and administration of regulatory and essential documents to all required Ethics Committees (EC) and regulatory bodies such as the Medicines Control Council (MCC), Institutional Biosafety Committee (IBC), administrative departments for Genetically Modified Organisms (GMO) or any other sponsor group
• This must be done in accordance with the protocol, Good Clinical Practice (GCP) and Sponsor requirements

• 7 Esselen Street, Hillbrow, Shandukani Clinical Research Site (CRS)

• Review and submit regulatory applications in a timeous and accurate manner (this includes amongst others initial protocol and amendment applications, recertifications, information updates, progress reports, investigator applications, IBs and PIs updates, and safety reporting)
• Submission and follow up of NHRD applications
• Submission and follow up of SANCTR applications
• Distribute requests for information and approvals within two business day of receipt
• Maintain all sections in ISF and/or eISF
• Create and update SharePoint and/or MS Teams (as applicable) with current documents
• Maintain SOP file and listing
• Lead weekly regulatory meetings with teams to plan regulatory updates and follow-up
• Update the minutes weekly on all studies for team meeting as required
• Provide constructive feedback and support to other team members
• Ensure the ,maintenance of tracking logs and systems for all submissions
• Assist with preparation and follow-up of monitoring visits and audits
• Create and/or provide study teams with current regulatory templates
• Support completion RRC cover letters
• Complete or follow-up on MTAs and execution there-of
• Submit and follow-up on export permits once completed
• Assist in troubleshooting and rectifying process flow problems in the regulatory process
• Training/corrective action for site staff based on QC/QA/External monitoring findings
• Track protocol approvals, recertification’s, translations, insurances, ICFs, LOAs, CMs and all other study documents
• Report and track critical events and protocol deviations – adhere to EC, MCC and Sponsor timelines of reportin
• Develop and/or review study specific SOPs when required
• Generate performance reports on studies on a monthly basis
• Distribute monitoring visit follow-up reports and follow-up letters to the site staff (if applicable) and ensure findings are attended to
• Ensure that 1-2-1 discussions are conducted with all staff regarding performance
• Ensure at least annual performance appraisals and probationary reviews are conducted with the regulatory Compliance Officers
• Ensure corrective action is implemented in terms of the code of conduct and in consultation with HR
• Ensure efficient manpower planning on a daily basis
• Take ownership and accountability for tasks & activities and demonstrates effective self-management
• Inform relevant parties in the event of tasks or deadlines not met and provide appropriate means of resolution
• Support and drives the business’ core values
• Maintain a positive attitude
• Take ownership for own career development
• Manage colleagues and client’s expectation and communicate appropriately
• Willing to help others and go the extra mile to meet team targets and objectives
• Be resourceful and efficient with managing the regulatory department

• Degree in a health related field

• At least 3 years’ experience in a clinical trial environment

• Certification in Good Clinical Practice (GCP)
• Human Subjects Protection
• OHRP and ongoing training modules on DAIDS Learning Management System
• Time Management
• Writing and presentation skills
• Must have excellent knowledge and understanding of the Local Ethics and Regulatory requirements, as well that of the FDA, NIH/DAIDS, OHRP and EMA
• Familiar with local and sponsor websites and resources e.g. DAIDS websites for HANC or networks, Wits HREC, MCC, DAFF, etc
• Attention to detail
• Organizational skills
• Problem solving skills
• Ability to work independently but must be a team player
• Assertive
• Ability to delegate if required
• Ability to guide and train study teams, understand the goals of projects and the unit

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV including a Cover letter
• 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 above criteria will not be considered for the respective position
• Wits Health Consortium will only respond to shortlisted candidates
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
• Closing date: 26 May 2026
• Note: No CV will be accepted after the closing date

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position