Regulatory Support Officer

The Regulatory Support Officer plays a critical execution role in ensuring all pharmaceutical products, documentation, and processes remain compliant with regulatory authorities (primarily FDA Ghana). This role supports the Regulatory Manager by handling submissions, documentation control, follow-ups, and coordination across departments.

1. Regulatory Submissions & Documentation

• Prepare and compile dossiers for product registration (new & renewals)
• Ensure all required documents (COA, GMP, labels, artwork, etc.) are complete and compliant
• Maintain up-to-date regulatory files for all products
• Track submission timelines and ensure zero delays

2. Liaison & Follow-Ups

• Actively follow up with FDA Ghana and other regulatory bodies
• Coordinate responses to queries, deficiencies, and variations
• Maintain strong working relationships with regulatory officers

3. Artwork & Label Compliance

• Cross-check packaging artworks against FDA guidelines before submission
• Work closely with the creative team to align design with compliance

4. Parallel Import Monitoring & Action

• Identify and flag cases of parallel imports / unauthorized market entries of company brands.
• Liaise with FDA Ghana to formally notify and escalate such cases
• Support enforcement actions in coordination with regulatory authorities and internal management
• Maintain a log of all parallel import cases and track resolution status

5. Internal Coordination

• Work with:

• Product Management
• QA/QC
• Supply Chain
• Ensure all departments provide required documentation

6. Regulatory Database & Tracking

• Maintain a live tracker of:

• Product registrations
• Expiry dates
• Pending approvals
• Variations and amendments
• Provide weekly updates to management

7. Audit & Compliance Support

• Assist in internal and external audits
• Ensure documentation is audit-ready at all timesSupport GMP and inspection preparations

• Degree in Pharmacy, Biomedical Science, Chemistry, or related field
• 1–4 years experience in regulatory affairs (pharma preferred)Experience dealing with FDA Ghana is a strong advantage
• Detail-oriented
• Good understanding of regulatory documentation
• Organized and process-drivenBasic understanding of pharma manufacturing & distribution