Regulatory Affairs and Document Controller

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

Regulatory Affairs & Document Control Specialist

Bulacan - Full-time | Onsite

About the Role

We are seeking an experienced Regulatory Affairs & Document Control Specialist to join a growing cosmetics manufacturing company. This role is responsible for managing regulatory submissions, maintaining product compliance, and overseeing document control processes to ensure all products and quality records meet Philippine FDA regulations and industry standards.

Responsibilities

• Prepare, submit, and monitor FDA product notifications and other regulatory requirements through the FDA eServices Portal.
• Develop, review, and maintain Product Information Files (PIF) and other regulatory documentation.
• Ensure compliance with Philippine FDA regulations, ASEAN Cosmetic Directive, and cosmetic labeling requirements.
• Review product labels, packaging, and marketing claims for regulatory compliance.
• Coordinate with R&D, QA, Production, and other departments to facilitate product 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 in accordance with document control procedures.
• Support FDA inspections, customer audits, and certification audits.
• Assist in maintaining an effective Quality Management System through proper documentation and compliance.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biology, Chemical Technology, Food Technology, or a related science field.
• Minimum of 1-2 years of Regulatory Affairs experience in a cosmetics manufacturing company.
• Hands-on experience using the Philippine FDA eServices Portal is required.
• Proven experience preparing and maintaining Product Information Files (PIF).
• Strong understanding of cosmetic regulations, ASEAN Cosmetic Directive, FDA requirements, and GMP.
• Experience in document control and quality documentation is highly preferred.
• Highly organized with excellent attention to detail and documentation skills.
• Willing to work onsite in Sta. Maria, Bulacan.

What We Offer

• Competitive salary and benefits package.
• Career growth and professional development opportunities.
• Comfortable staff house accommodation for employees relocating from outside Bulacan.
• Opportunity to work in a dynamic cosmetics manufacturing environment focused on innovation, quality, and regulatory excellence.