Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will ensure that all company products meet the regulatory requirements of the FDA Ghana and GSA. This role involves preparing dossiers, monitoring compliance, and supporting cross‑functional teams to maintain high standards of product safety and quality.

Key responsibilities

• Prepare, assemble, and submit registration dossiers for new products, variations, and renewals to the FDA Ghana and GSA.
• Monitor and ensure adherence to Good Manufacturing Practices (cGMP) within the manufacturing facility, including preparation for inspections.
• Review product labels, packaging inserts, and promotional materials to ensure compliance with FDA guidelines before market release.
• Stay up‑to‑date with changes in national and international regulations and interpret their impact on company products.
• Collaborate with QA, Production, and R&D teams to keep technical documentation accurate and current.
• Manage product recalls, adverse event reporting, and the safe disposal of non‑conforming products.

Required profile

Required skills

• Knowledge of cGMP requirements.
• Familiarity with FDA Ghana and GSA regulatory processes.
• Experience reviewing product labeling and promotional material for regulatory compliance.
• Ability to manage product recalls and adverse event reporting.

What we offer

• Opportunity to work within a dynamic regulatory environment.
• Collaboration with cross‑functional teams.
• Professional development in regulatory affairs.