Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
- Coordinating and performing various regulatory duties including, but not limited to, the collection, compilation and preparation of materials for submission to regulatory and other related bodies in line with TASK SOPs, policies and guidelines
- Following standard procedures, processes and regulations for the collection and processing of study site documents / essential documents and site information for study submissions and other continuous communication with SAHPRA and Ethics committees
- Ensuring review of initial protocol and ICF to ensure alignment with country specific guidelines. This includes adding the site-specific requirements where needed and identifying regulatory risks and advise on mitigation strategies
- Managing and leading the team in line with TASK values and strategic objectives
- Ensuring compliance with ongoing reporting requirements to local regulatory authorities and ethical committees and in line with international requirements, where applicable
- Effectively addressing and or responding to requests / enquiries from local and global regulatory agencies
- Providing regulatory direction to all stakeholders, devising strategies where needed
- Exercising a proactive and flexible approach to resolving any issues and mitigating risks
- Communicating with regulatory and governmental agencies to build and maintain professional relationships and where necessary coordinating meetings with Regulatory and related bodies
- Developing and/or reviewing standard operating procedures as required
- May be required to act as a representative and collaborate on local and international projects and regulatory initiatives
- Coordinating site start up activities, from feasibility, contracting, to site activation
- Working with internal teams to meet deliverables
- Attending team and operational team meetings and providing updates
- Coaching junior staff members to enhance competency, quality and regulatory expertise and to maintain team morale
- Act as regulatory lead in the absence of the Head of Regulatory
Ideal Requirements
- Honours or Master’s degree, or equivalent work experience, in a scientific or healthcare discipline or related field
- Advanced knowledge and experience in clinical trial regulatory functions (3+ years of previous clinical trial / regulatory / quality assurance experience) i.e., SAHPRA submissions, ethics committees, and regulatory tracking systems (preferred)
- Excellent understanding of global / regional / national country requirements / regulatory affairs procedures and Research Ethics for clinical trial authorisation
- Expert knowledge of ICH, SA Good Clinical Practice and other global regulatory guidelines
- 2+ years at a management level
- Excellent computer skills, including MS Office Suite
- Valid GCP certificate / previously attended GCP
- Presentation / facilitation experience and / or wiliness to facilitate courses at TASK
- Project management experience (advantageous)
- Valid Driver’s license
Key Personal Inherent Characteristics
- Strong writing, communication, negotiation and interpersonal skills
- Strong attention to detail, demonstrate initiative, ability to multi-task and to balance competing priorities
- Capable of working independently and exercising independent judgement
- Strong problem solving and analytical skills
Details:
Area: Parow, Cape Town
Contract Type: Permanent
Applications Close: 22 April 2026 (10:00)
If you have not received a response within one month, your application was most likely unsuccessful.
TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.
We believe great talent comes in many forms and encourage suitably qualified candidates with disabilities to apply. Meeting our employment equity goals will be acknowledged during the recruitment process.
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.
