About the Role
Zamiva Transnational Services, a leading human capital development and management consultancy in Lagos, is seeking a dynamic and experienced Assistant Manager, Regulatory Affairs to drive our regulatory compliance and product registration initiatives.
Key ResponsibilitiesAs the Assistant Manager, Regulatory Affairs, you will play a pivotal role in ensuring our operations comply with all relevant statutory frameworks in Nigeria. Your core duties will include:
- Prepare, review, and coordinate regulatory submissions for new pharmaceutical and related products.
- Manage product registration, renewals, variations, and post-approval applications with regulatory bodies.
- Prepare and review Common Technical Document (CTD) dossiers and supporting documentation for accuracy and consistency.
- Coordinate prompt responses to regulatory queries and deficiency letters.
- Act as the primary liaison between Zamiva Transnational Services and regulatory authorities like NAFDAC and SON.
- Coordinate regulatory inspections, official meetings, and agency communications.
- Maintain comprehensive trackers for product registration statuses and regulatory submissions.
To qualify for this exciting career opportunity, candidates must meet the following criteria:
- Bachelor's Degree in Pharmacy, Industrial Chemistry, or allied disciplines.
- A Master's Degree or relevant postgraduate qualification is an added advantage.
- Minimum of five (5) years of proven experience in Regulatory Affairs within the Nigerian market.
- Demonstrated expertise in managing NAFDAC product registrations, renewals, and variations.
- Deep understanding of NAFDAC guidelines, SON standards, and applicable Nigerian regulatory frameworks.
- Prior supervisory or managerial experience in a pharmaceutical manufacturing or regulatory environment is highly preferred.
We offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment within a fast-growing consultancy.