Cosmetics Regulatory Affairs & Documentation Lead — Onsite

Primelab Cosmetics Manufacturing Inc.; Bulacan; On-site; PHP 350,000 - 700,000; Full time

Benefits offered by this job

Competitive salary

Relocation housing

Career growth

Regulatory excellence

Job summary

Primelab Cosmetics Manufacturing Inc. is seeking a Regulatory Affairs & Document Control Specialist to manage regulatory submissions and ensure product compliance at our Sta. Maria, Bulacan facility.

The role covers FDA notifications, PIF maintenance, labeling reviews, and cross-functional coordination for registrations and launches. The candidate will monitor regulatory updates, maintain controlled documents, and support inspections and audits to uphold our quality management system and

Qualifications

• Minimum 1–2 years of Regulatory Affairs experience in cosmetics manufacturing.
• Hands-on experience using the Philippine FDA eServices Portal.
• Proven experience preparing and maintaining Product Info Files (PIF).
• Strong understanding of cosmetic regulations, ASEAN Cosmetic Directive, FDA requirements, and GMP.
• Experience in document control and quality documentation is preferred.
• Willing to work onsite in Sta. Maria, Bulacan.

Responsibilities

• Prepare, submit, and monitor FDA product notifications via the FDA eServices Portal.
• Develop, review, and maintain Product Information Files (PIF).
• Ensure compliance with Philippine FDA regulations, ASEAN Cosmetic Directive, and labeling requirements.
• Review product labels, packaging, and marketing claims for regulatory compliance.
• Coordinate with R&D, QA, Production to facilitate registrations and launches.
• Monitor regulatory updates and communicate changes affecting products and operations.
• Maintain controlled documents, including SOPs, specifications, forms, and quality records.
• Manage document revisions, approvals, issuance, and archival per procedures.
• Support FDA inspections, customer audits, and certification audits.
• Assist in maintaining an effective Quality Management System through proper documentation.

Skills

Regulatory affairs

Document control

Attention to detail

Cross-functional coordination

Education

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biology, Chemical Technology, or related science

Tools

Philippine FDA eServices Portal

Job description

Primelab Cosmetics Manufacturing Inc. is seeking a Regulatory Affairs & Document Control Specialist to manage regulatory submissions and ensure product compliance at our Sta. Maria, Bulacan facility.

The role covers FDA notifications, PIF maintenance, labeling reviews, and cross-functional coordination for registrations and launches. The candidate will monitor regulatory updates, maintain controlled documents, and support inspections and audits to uphold our quality management system and