Regulatory Affairs Pharmacist

Lifestrong Marketing Inc.; Caloocan; On-site; PHP 446,000 - 725,000; Full time

Job summary

Lifestrong Marketing Inc. is seeking a Regulatory Affairs Pharmacist to ensure FDA compliance for all cosmetics products. You will help develop regulatory strategies, manage inspection readiness, and coordinate FDA correspondence and product registrations.

You will register cosmetics with the FDA, prepare licenses, handle notices, monitor regulatory changes, verify formulations meet standards, and mentor junior staff while liaising with manufacturers and suppliers for file updates.

Qualifications

• Knowledge of FDA rules and policies relevant to cosmetics.
• Strong written and oral communication skills.
• Excellent organizational skills and attention to detail.

Responsibilities

• Register cosmetics and personal care products with the FDA.
• Prepare for initial or renewal of LTO licenses and coordinate with FDA inspectors.
• Handle and resolve FDA Notices of Compliance.
• Maintain current knowledge of regulations in cosmetics and ASEAN directives.
• Ensure formulations comply with Philippine FDA standards and are within approved limits.
• Ensure warehouses comply with FDA requirements.
• Conduct product testing for finished goods distributed and imported.
• Schedule monthly warehouse visits and coordinate pest control.
• Train and mentor junior pharmacists on regulatory functions.
• Prepare monthly task updates for the regulatory manager.
• Assist in answering customer inquiries and concerns.
• Coordinate with manufacturers for Product Information File filings per ASEAN Cosmetics Directive.
• Process initial and renewal MOA with manufacturers.
• Request updated GMP and ISO from manufacturers.
• Conduct annual supplier and toll manufacturer audits.

Skills

FDA regulations knowledge

Regulatory strategy development

Written and oral communication

Attention to detail

Organizational skills

Education

Pharmacist degree

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.