Regulatory affairs officer

Job Summary:

We are seeking a knowledgeable and detail-oriented Regulatory Affairs Officer to lead and oversee all regulatory processes for our product lines including pharmaceuticals, food, and cosmetic products. The ideal candidate is a licensed pharmacist with a strong background in compliance with Philippine FDA (Food and Drug Administration) regulations and relevant international standards.

Key Responsibilities:

• Regulatory Strategy & Compliance
• Ensure all products meet Philippine FDA regulatory requirements.
• Develop and execute regulatory strategies for new product registrations, renewals, and amendments.
• Monitor and interpret relevant local and international regulations, laws, and guidelines that impact the company’s operations.
• Product Registration
• Lead end-to-end registration processes for food, drug, and cosmetic products.
• Prepare, compile, and submit regulatory dossiers and ensure timely approval.
• Liaise and coordinate with government agencies (e.g., FDA, DOH, BOC) on product-related submissions.
• Labeling & Advertising Compliance
• Review product packaging, labeling, and marketing materials to ensure compliance with regulatory guidelines.
• Provide regulatory advice during product development and marketing planning stages.
• Audit & Inspection Readiness
• Ensure company readiness for regulatory inspections and audits.
• Maintain up-to-date regulatory files and documentation for internal and external use.
• Cross-functional Coordination
• Collaborate with R&D, Quality Assurance, Legal, and Marketing departments to ensure regulatory alignment.
• Serve as the company’s primary contact for regulatory bodies.

Qualifications:

• Licensed Pharmacist in the Philippines (required)
• Bachelor’s degree in Pharmacy (required with license)
• At least 5 years of experience in Regulatory Affairs, preferably with exposure to multi-category products (drugs, food, cosmetics)
• Strong knowledge of Philippine FDA laws and ASEAN regulatory frameworks
• Excellent communication and documentation skills
• Detail-oriented with strong organizational and leadership capabilities