Regulatory Affairs Pharmacist

Lifestrong Marketing Inc.; Caloocan; On-site; PHP 400,000 - 700,000; Full time

Job summary

Lifestrong Marketing Inc. seeks a Regulatory Affairs Pharmacist to ensure FDA compliance across cosmetics products and to develop regulatory strategies. The role involves FDA correspondence, product registration, and renewal processes, with strong emphasis on accuracy and regulatory knowledge.

You will coordinate licenses, inspections, supplier audits, and Product Information Files, while training junior staff and communicating regulatory updates to multiple departments.

Qualifications

• Knowledgeable in FDA rules and policies
• Strong written and oral communication
• Excellent organization and attention to detail

Responsibilities

• Register cosmetics and personal care products with FDA
• Prepare for LTO licenses and coordinate with FDA inspectors
• Handle and resolve FDA Notices of Compliance
• Maintain updated knowledge of cosmetics regulations and guidelines
• Ensure formulations meet Philippine FDA standards and approved limits
• Ensure warehouses comply with FDA requirements
• Conduct product testing for finished goods and imports
• Schedule monthly warehouse visits and pest-control coordination
• Assist in updating departments on regulatory requirements and advisories
• Train and mentor junior pharmacists in regulatory functions
• Prepare monthly task updates for the regulatory manager
• Conduct product testing and investigate customer complaints
• Answer customer inquiries and concerns
• Handle cosmetics from suppliers (local and imported)
• Conduct annual supplier and toll manufacturer audits
• Coordinate with manufacturers for Product Information Files under ASEAN Cosmetics Directive
• Process MOA updates and requests for updated GMP/ISO from manufacturers

Job description

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.
• 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.