The Regulatory Affairs Pharmacist ensures our company's FDA compliance with all relevant regulations across our Cosmetics products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules and policies, strong written and oral communication, organization skills and good attention to details are required for this role.
Compliance and Control:
- Register our cosmetics and personal care product at FDA.
- Prepare for initial or renewal of LTO licenses and coordinate with the FDA inspector
- Handle and resolve Notice of Compliance from FDA
- Maintain current knowledge of relevant regulations in Cosmetics and keeping up to date with the changes in regulatory legislation and guidelines.
- Ensures that formulation confirms to Philippine FDA standards and is within the approved limit.
- Ensures that assigned warehouses are compliant with FDA requirements.
- Conducts product test for all finished goods distributed and imported by the company.
- Schedules and facilitate monthly warehouse visit and coordinate the schedule of pest control
Team Management:
- Assist in updating related departments and the management on latest regulatory requirements and FDA advisories.
- Trains and mentor junior pharmacist on regulatory functions
- Prepares monthly tasks update to regulatory manager.
Customer Relations:
- Conducts product test and investigate product complaints.
- Assists in answering customer inquiries and concerns.
Suppliers:
- Assigned to handle cosmetic products from imported and local suppliers.
- Conducts annual suppliers and toll manufacturer audits.
- Coordinates with manufacturers for Product Information File for filing based on ASEAN Cosmetics Directive.
- Process initial and renewal of memorandum of agreements from manufacturers.
- Request for updated GMP and ISO from manufacturers.
