Regulatory Affairs Associate

6 days ago

Caloocan City, National Capital Region, Philippines Lifestrong Marketing Inc. Full time ₱800,000 - ₱1,200,000 per year

Job Overview/ Key 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).

Technical Skills:

  • 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

Behavioral Skills:

  • 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.

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