Job Summary:

The Regulatory Affairs Specialist ensures that all cosmetic products comply with the regulatory requirements of the Philippines Food and Drug Administration (FDA) and other relevant agencies. The role involves handling product notifications, ingredient compliance, labeling, and ensuring overall regulatory readiness for product launches and imports.

Key Responsibilities:

• Ensure all cosmetic products are properly notified with the FDA through the eNotification Portal before market release.
• Review product formulations to ensure compliance with the Philippine ASEAN Cosmetic Directive (ACD), especially restricted or banned substances.
• Check that product labels meet local labeling requirements, including proper product name, net content, manufacturer/importer info, batch number, manufacturing and expiry dates, and usage instructions.
• Prepare and manage product technical documents (e.g., Product Information File – PIF) and ensure completeness for FDA inspections or audits.
• Review and approve marketing materials to ensure claims (e.g. whitening, anti-aging) are compliant with cosmetic classification (not overstating therapeutic benefits).
• Monitor changes in Philippine FDA and ASEAN cosmetic regulations, and update internal teams accordingly.
• Assist in securing import permits and ensuring documentation is in place for customs clearance and FDA inspections.
• Work with R&D, Quality Assurance, Marketing, and Supply Chain teams to support compliant product development and launches.

Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field
• At least 1–3 years of experience in regulatory affairs (preferably cosmetics or personal care)
• Familiarity with FDA Philippines requirements, ASEAN Cosmetic Directive, and related laws (e.g. RA 3720 as amended)
• Good organizational and communication skills
• Detail-oriented, with ability to manage multiple regulatory submissions