Regulatory Pharmacist

About the role

Phil Asia Medica is hiring a licensed Pharmacist to handle FDA requirements. You will make sure products are registered, licenses stay valid, and everything labelled, advertised, and sold follows the rules. This is a desk-based compliance role with a lot of paperwork and follow-ups with the FDA.

Key responsibilities

• Prepare, file, and track product registrations (CPR) and renewals with the FDA
• Keep the License to Operate and other company permits valid and renewed on time
• Check labels, packaging, and inserts against FDA requirements before printing
• Review promotional materials and medical rep presentations for approved, accurate claims
• Coordinate with suppliers, principals, and the warehouse to collect documents for submissions
• Report adverse drug reactions and product complaints to the FDA within deadlines
• Prepare the company for FDA inspections and respond to findings
• Keep regulatory files, SOPs, and compliance records complete and easy to find
• Track new FDA circulars and tell the team what needs to change