This role is critical in shaping regulatory strategy, ensuring compliance, and enabling successful market expansion for both human pharmaceutical and animal health products.
The successful candidate
will lead:
- Regulatory strategy development and execution
- ACTD/CTD dossier preparation and submissions
- Product registrations, renewals, and lifecycle management
- Regulatory engagement across multiple African countries
- Coordination with CMOs, CROs, QA, R&D, and Supply Chain teams
- Implementation of RIMS and digital regulatory systems
- Team leadership, capability building, and performance management
Key Requirements
To
be considered for this role, candidates should have:
- Bachelor’s degree in Pharmacy, Veterinary Medicine, Pharmaceutical
Sciences, or a related scientific field
- Minimum 7+ years of regulatory affairs experience within the
pharmaceutical industry, with exposure to African markets
- Strong experience in ACTD/CTD dossier preparation, submission, and
review
- Proven experience in product registrations, renewals, variations,
and lifecycle management
- Experience working with both locally manufactured products and CMOs
(preferred)
- Experience coordinating bioequivalence studies with CROs (preferred)
- Strong understanding of pharmaceutical regulatory frameworks across
multiple African countries
- Experience with regulatory systems, tracking tools, or RIMS
platforms is an added advantage
- Strong leadership, stakeholder management, and cross-functional
collaboration skills
How to Apply
Send Cv
to jobs@talentgridafrica.com
