FDA Regulatory Affairs Specialist – Cosmetics & Pharma

Dayabumi Distribution Mabulo Inc.; Camarines Sur; Sur place; PHP 550 000 - 900 000; Plein temps

Résumé du poste

Dayabumi Distribution Mabulo Inc. is urgently hiring a Regulatory Affairs Officer / Regulatory Pharmacist to oversee Philippine FDA regulatory requirements for cosmetics and pharmaceutical products.

You will manage CPNs, LTOs, labeling, and regulatory documentation to bring products to market efficiently while maintaining strict compliance. The role requires hands-on experience with FDA processes, strong documentation skills, and the ability to coordinate with the regulator across eServices and

Qualifications

• Must have regulatory knowledge for cosmetics and pharmaceutical products
• Experience with CPN and LTO processes for cosmetics
• Strong documentation and regulatory filing skills
• Familiarity with Philippine FDA requirements and labeling rules
• Detail-oriented with ability to manage multiple SKUs and deadlines

Responsabilités

• Handle end-to-end FDA Certificate of Product Notification (CPN) applications for cosmetics products
• Manage new registrations, renewals, amendments, and variations
• Assist in maintaining and renewing the company’s FDA License to Operate (LTO)
• Prepare, organize, review, and submit regulatory dossiers and supporting documents
• Coordinate with Philippine FDA via online/eServices systems
• Maintain an organized regulatory tracker for all products and statuses
• Assist in audit readiness for FDA inspections and post-market activities
• Identify compliance risks and suggest process improvements

Connaissances

Regulatory affairs

FDA experience

Pharmacist

Labeling/claims review

Documentation

Formation

Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biology, Chemical Engineering

Outils

FDA eServices

Description du poste

Dayabumi Distribution Mabulo Inc. is urgently hiring a Regulatory Affairs Officer / Regulatory Pharmacist to oversee Philippine FDA regulatory requirements for cosmetics and pharmaceutical products.

You will manage CPNs, LTOs, labeling, and regulatory documentation to bring products to market efficiently while maintaining strict compliance. The role requires hands-on experience with FDA processes, strong documentation skills, and the ability to coordinate with the regulator across eServices and