Regulatory Affairs Associate

Regulatory Affairs Associate (Pharmacist) Responsibilities 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. 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. Coordinate with manufacturers/suppliers for documentation; support annual supplier audits; ensure alignment with ASEAN Cosmetic Directive requirements. Ensure formulations and labels comply with FDA standards; prepare monthly RA activity reports; contribute to process improvements impacting RA/QA. 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). 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. #J-18808-Ljbffr