Regulatory Support Officer
Prosupport Services Company Limited · Accra
Job description
About the role
The Regulatory Support Officer will ensure that all pharmaceutical products, documentation and processes remain compliant with the Ghana Food and Drugs Authority (FDA). Working closely with the Regulatory Manager, the role involves preparing submissions, controlling documentation, and coordinating with internal teams and external authorities.
Key responsibilities
- Prepare and compile dossiers for product registration, including new applications and renewals.
- Maintain up‑to‑date regulatory files and track submission timelines to avoid delays.
- Actively follow up with FDA Ghana, respond to queries, deficiencies and variations, and maintain strong relationships with regulatory officers.
- Cross‑check packaging artwork and labels against FDA guidelines and collaborate with the creative team.
- Identify and flag parallel import cases, notify FDA Ghana and support enforcement actions.
- Coordinate with Product Management, QA/QC and Supply Chain to gather required documentation.
- Maintain a live regulatory tracker covering registrations, expiry dates, pending approvals and variations, and provide weekly updates to management.
- Assist in internal and external audits, ensuring all documentation is audit‑ready.
Required profile
- Degree in Pharmacy, Biomedical Science, Chemistry or a related field.
- 1–4 years of experience in regulatory affairs, preferably within the pharmaceutical sector.
- Experience dealing with FDA Ghana is a strong advantage.
- Detail‑oriented, organized and process‑driven with a basic understanding of pharma manufacturing and distribution.
Required skills
- Regulatory submissions
- FDA Ghana liaison
- Pharmaceutical documentation control
- GMP knowledge
- Artwork and label compliance
What we offer
- Competitive salary commensurate with experience.
- Flexible working arrangements where applicable.
- Collaborative, growth‑oriented team culture with ongoing learning and development support.
- Access to premium tools and platforms to perform at your best.
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Published 1 month ago
Expires 2 days from now
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Prosupport Services Company Limited
Accra