Regulatory Affairs Officer

About the role

The Regulatory Affairs Officer ensures that all company products meet the requirements of the Food and Drugs Authority (FDA Ghana), Ghana Standards Authority (GSA) and other relevant bodies. You will manage regulatory submissions, support cGMP compliance, and coordinate cross‑functional activities to keep products market‑ready.

Key responsibilities

• Prepare, compile and submit registration dossiers for new products, variations and renewals to FDA Ghana and GSA.
• Monitor and support compliance with current Good Manufacturing Practices (cGMP) and assist with regulatory inspections and audits.
• Review labels, package inserts, artwork and promotional materials for regulatory conformity before market release.
• Stay informed on local and international regulatory changes and evaluate their impact on operations.
• Collaborate with Quality Assurance, Production and R&D to maintain accurate technical and regulatory documentation.
• Coordinate product recalls, adverse event reporting and disposal of non‑conforming or expired items.
• Maintain organized records of licenses, certificates and correspondence with authorities.
• Support internal regulatory and quality improvement initiatives as assigned.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Microbiology or a related life‑science field.
• Experience in regulatory affairs, quality assurance or pharmaceutical manufacturing is an advantage.
• Good understanding of FDA Ghana and GSA regulatory requirements.
• Knowledge of cGMP and quality management systems.
• Strong attention to detail, analytical and problem‑solving abilities.
• Excellent communication and interpersonal skills for cross‑department collaboration.

Required skills

• Proficiency in Microsoft Office applications.
• Familiarity with regulatory documentation systems.