The Regulatory Affairs Manager leads the company's regulatory strategy, compliance operations, and FDA interactions across Cosmetics, Personal Care, Medical Devices, Drugs, Food Supplements, and other regulated product categories.
You will oversee a team of Regulatory Officers and ensure that all products, warehouses, systems, and processes comply with Philippine FDA rules, ASEAN Cosmetics Directive, and other relevant regulatory frameworks for cosmetics, drugs, and food supplements.
This position requires strong regulatory expertise, leadership skills, and the ability to manage high-volume registrations and cross-category compliance in a fast-paced FMCG environment.
1. Regulatory Strategy & Compliance Leadership
- Develop and implement regulatory strategies for product registration, licensing, and compliance across all brands and categories.
- Ensure full compliance with FDA regulationsCosmetics, Personal Care, Medical Devices, HUHS, GMP/ISO requirements, labeling guidelines, and ASEAN directives.
- Lead the execution of FDA regulatory submissions including:
- Cosmetic notifications (initial and renewal)
- Establishment licenses (LTO initial and renewal)
- Warehouse licenses and compliance documentation
- Act as primary company representative for FDA audits, inspections, meetings, and regulatory correspondence.
- Lead the timely resolution of Notice of Violations, Notice of Deficiencies, Notice of Compliance, and other regulatory findings.
- Maintain updated knowledge of regulatory changes, and develop internal guidelines and SOP revisions based on new rulings.
2. Product Registration, Evaluation & Documentation
- Oversee entire product registration cyclefrom data collection, dossier preparation, PIF consolidation, up to approval.
- Validate and approve product formulations to ensure compliance with:
- ASEAN Cosmetics Directive
- FDA concentration limits and ingredient restrictions
- Labeling requirements
- Supervise supplier and toll manufacturer documentation:
- GMP/ISO certificates
- PIF documentation
- Safety Data Sheets
- Product technical dossiers
- Ensure accurate and compliant product labeling, artworks, and marketing claims.
3. Warehouse, Quality, and Compliance Oversight
- Ensure all company warehouses and storage facilities comply with FDA and GMP requirements.
- Approve pest control schedules, sanitation procedures, and operational compliance programs.
- Lead quarterly/annual audits of warehouses, toll manufacturers, and suppliers to ensure continued compliance.
4. Team Leadership & People Development
- Manage and mentor Regulatory Officers, Pharmacists, and support staff.
- Set KPIs, monitor performance, coach individual team members, and oversee workload distribution.
- Conduct regular team trainings on regulatory updates, SOP changes, FDA advisories, and compliance best practices.
- Prepare monthly and quarterly compliance and task reports for senior management.
5. Cross-Functional Coordination
- Collaborate with:
- Brand Marketing & NPD for new product development regulatory requirements
- Purchasing for supplier validations
- Warehousing & Logistics for compliance and inspection readiness
- Customer Care for product complaints and regulatory inquiries
- QA/QC for product testing and quality investigations
- Ensure regulatory timelines are aligned with product launch deadlines and supply chain schedules.
6. Customer & Market Support
- Oversee the investigation and documentation of product complaints or adverse events.
- Approve regulatory responses to consumer inquiries and customer concerns.
- Support Sales, Trade Marketing, and Key Accounts teams with compliance documents required by Watsons, SM, Robinsons, Lazada/Shopee, etc.
7. Supplier & Manufacturer Compliance
- Lead annual compliance audits of suppliers and toll manufacturerslocal and international.
- Ensure all MOAs, GMP certificates, ISO documents, SDS, CFS, and PIFs are updated and valid before product launch.
- Coordinate regulatory requirements for imported products, including importation compliance, labeling validation, and documentation review.
