Regulatory Affairs Specialist  

Regulatory
• Prepares and submits product registration dossiers to the Philippine FDA.
• Evaluates dossiers for quality and completeness.
• Prepares and submits product registration dossiers to export country affiliates/distributors.
• Maintains Licenses to Operate and Certificates of Foreign Good Manufacturing Practice with the FDA.
• Handles promotional permit applications and submits to the FDA.
• Coordinates with regulatory agencies on registrations, variations, and permits.
• Manages product information in various databases.
• Prepares and reviews procedural documents for FDA submissions and commercial orders.
• Ensures valid processes for packaging transitions.
• Provides customer support for product inquiries and transport documents.

Medical - Strategic Marketing Support:
• Handles packaging artworks for product registration or promotions.
• Manages pharmacovigilance activities and reports adverse events to the FDA.
• Coordinates quality-related complaints and suspected counterfeit products.
• Supports marketing efforts with necessary documents.

Medical Education Programs:
• Prepares educational materials for divisional programs.
• Implements medical training for personnel and partners.

Advertising Claims Support:
• Researches and provides medical information for product claims and brand communication.
• Reviews and updates packaging text for relevant claims.
• Assists in filing complaints against competitor products.
• Coordinates product inclusion in medical directories (MIMS, PPD).

• Graduate of a Bachelor’s Degree in Pharmacy
• Must be a licensed pharmacist
• With 3 to 6 years of experience in regulatory and/or medical affairs
• Knowledgeable in FDA guidelines and medical information
• Must have good interpersonal skills and able to work well independently
• With keen attention to detail, and has the ability to multi-task and meet strict deadlines