Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 35 years, we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products across various therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory, and nutrition. We have a track record few can match and our brands are among the most trusted in Africa.
Location: Ogun
Job Description
- The Regulatory Pharmacist is responsible for ensuring that all pharmaceutical products manufactured by the company comply with national and international regulatory requirements. The role involves preparation, submission, and maintenance of product dossiers, coordination with regulatory authorities eg NAFDAC), and ensuring continuous compliance throughout the product lifecycle.
- Ensure all manufactured products comply with current regulatory requirements, guidelines, and pharmacopeial standards.
- Monitor changes in regulatory laws, guidelines, and policies and communicate implications to management.
- Support implementation of regulatory updates into manufacturing, quality, and documentation systems.
- Ensure compliance with GMP, GDP, and regulatory inspection requirements.
- Serve as the primary contact between the company and regulatory agencies.
- Coordinate and support regulatory inspections, audits, and facility assessments.
- Respond promptly to regulatory queries, deficiency letters, and compliance observations.
- Follow up on pending approvals and regulatory correspondences.