
Regulatory Affairs Pharmacist
4 weeks ago
Overview
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 detail are required for this role.
Responsibilities- Register our cosmetics and personal care products with the FDA.
- Prepare for initial or renewal of LTO licenses and coordinate with the FDA inspector.
- Handle and resolve Notices of Compliance from the FDA.
- Maintain current knowledge of relevant regulations in Cosmetics and keep up to date with changes in regulatory legislation and guidelines.
- Ensure that formulations comply with Philippine FDA standards and are within the approved limits.
- Ensure that assigned warehouses are compliant with FDA requirements.
- Conduct product tests for all finished goods distributed and imported by the company.
- Schedule and facilitate monthly warehouse visits and coordinate pest control schedules.
- Assist in updating related departments and management on latest regulatory requirements and FDA advisories.
- Train and mentor junior pharmacists on regulatory functions.
- Prepare monthly tasks updates to regulatory manager.
- Conduct product testing and investigate product complaints.
- Assist in answering customer inquiries and concerns.
- Handle cosmetic products from imported and local suppliers.
- Conduct annual suppliers and toll manufacturer audits.
- Coordinate with manufacturers for Product Information File filing based on ASEAN Cosmetics Directive.
- Process initial and renewal of memoranda of agreement with manufacturers.
- Request updated GMP and ISO documents from manufacturers.
- Seniority level : Mid-Senior level
- Employment type : Full-time
- Job function : Legal
- Industries : Retail
Taguig, National Capital Region, Philippines
NotesWe are not including boilerplate postings or external job advertisements. This description reflects the responsibilities and expectations for the Regulatory Affairs Pharmacist role.
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