Job Description
Job Summary
The Regulatory Affairs Officer (FDA & Import Compliance) supports the FDA Liaison Supervisor in ensuring compliance with local and international regulatory requirements. This role is responsible for managing product registrations, licenses, and accreditations, and representing the company during regulatory inspections.
Key Responsibilities
Manage applications and renewals of Certificates of Accreditation and other regulatory licenses, including:
Bureau of Customs (Certificate to Import)
Food and Drug Administration (Importer License and Retail Store Licenses)
Bureau of Animal Industry (for Bow & Wow stores)
National Meat Inspection Service (NMIS)
Bureau of Plant Industry (BPI)
Handle product registrations with FDA, BAI, NMIS, BPI, and other relevant government agencies
Process import-related regulatory requirements such as Add Source, Permit to Import, and similar documentation
Act as the company representative during government inspections, ensuring compliance while safeguarding company and customer interests
Ensure retail stores are supported by a licensed store pharmacist
Prepare and submit regulatory documentation for newly opened retail stores
Maintain strict confidentiality of regulatory documents and company information
Performance Indicators
Number of completed product registrations
Timely renewal of CoA, LTO, and all regulatory licenses
Accurate, complete, and on-time submission of required reports
Qualifications
Graduate of Nutrition, Pharmacy, or a related field
Strong communication and negotiation skills
Analytical and detail-oriented, with a data-driven approach
Able to manage multiple tasks in a fast-paced environment
Flexible, adaptable, and open to change
Honest, trustworthy, and professional
Strong interpersonal skills; approachable and collaborative
Team-oriented and receptive to feedback
