About the Role
Afrab-Chem Limited, a leading pharmaceutical manufacturing pioneer in Nigeria established in 1968, is seeking a dedicated and detail-oriented Regulatory Officer to join our dynamic compliance team. In this role, you will play a crucial part in ensuring our extensive range of high-quality pharmaceutical products successfully navigates regulatory frameworks and meets all statutory standards.
Key Responsibilities- Prepare and compile comprehensive product dossiers for submission to relevant health authorities.
- Manage the entire drug registration process efficiently from initiation to approval.
- Prepare Periodic Safety Update Reports (PSVR) and maintain rigorous pharmacovigilance documentation.
- Ensure continuous alignment with local and international pharmaceutical regulations and guidelines.
- Conduct regular regulatory follow-ups and liaise proactively with regulatory agencies.
- Maintain up-to-date knowledge of evolving regulatory landscapes within the Nigerian healthcare sector.
- Bachelor's degree in Pharmacy, Biochemistry, Chemistry, or a related scientific discipline.
- Proven professional experience in dossier preparation and drug registration within the pharmaceutical industry.
- In-depth understanding of regulatory affairs, compliance frameworks, and regulatory follow-up procedures.
- Strong analytical, communication, and organizational skills.
- Ability to interpret complex regulatory guidelines and implement them effectively.
- Competitive salary and performance-based incentives.
- Comprehensive health insurance coverage.
- Opportunities for professional development in a reputable manufacturing environment.
- A collaborative and growth-oriented workplace culture.