Regulatory Affairs Associate

Responsibilities

• Documentation: Prepare and maintain Product Information Files; file and organize FDA-related documents (CPRs, CPNs, LTOs, permits, contracts, audit findings, etc.); monitor license renewals; generate and monitor GS1 barcodes; ensure retention labels and LTO documents are FDA-compliant.
• Operations: Monitor and track regulatory submissions and follow-ups; ensure timely updates and compliance with FDA guidelines; check FDA e-Portal for approved CPRs/CPNs and update records; assist inspectors during FDA inspections.
• Suppliers: Coordinate with manufacturers/suppliers for documentation; support annual supplier audits; ensure alignment with ASEAN Cosmetic Directive requirements.
• Compliance & Reporting: Ensure formulations and labels comply with FDA standards; prepare monthly RA activity reports; contribute to process improvements impacting RA/QA.
• Other Duties: Perform other tasks as required by FDA or assigned by RA/QA Supervisor/Manager.

Qualifications

• Graduate of BS Pharmacy, Chemistry, Cosmetic Science, Biology, or other health-related course.
• Preferably with experience in regulatory affairs (Drug, Food, Medical Device); willing to learn Cosmetics.
• Preferably with valid PRC ID (Pharmacy or related field).
• Knowledge of regulatory terminology, FDA/ASEAN requirements, and submission tools.
• Proficient in Microsoft Office (Word, Excel).\Strong documentation and record-keeping skills.
• Familiar with FDA e-Portal, CPR/CPN processes, and GS1 barcode management.
• Understanding of label and formulation compliance with FDA standards.
• Experience in preparing/maintaining dossier or product information file.
• Strong analytical and decision-making skills.
• Excellent time management and attention to detail.
• Flexible and can adapt to changing priorities.
• Able to work independently with minimal supervision.
• Effective written and oral communication.
• Team player, able to work harmoniously across departments and with external stakeholders.