Key Responsibilities
1. Regulatory Submission & Product Registration
- Prepare, compile, and submit regulatory dossiers and documentation for product registration and license applications
- Coordinate product registration with Thai FDA, OCPB, and other relevant authorities
- Ensure timely renewal of licenses, permits, and product approvals
- Maintain accurate regulatory documentation and filing systems
2. Product Compliance Review
- Review product formulations, ingredients, and labeling to ensure compliance with regulatory requirements prior to submission
- Verify claims, packaging artwork, and marketing materials in alignment with regulatory standards
- Identify compliance risks and recommend corrective actions
3. Regulatory Monitoring & Updates
- Monitor updates in laws, regulations, and regulatory announcements
- Support the implementation of regulatory changes into internal processes
- Provide regulatory guidance to cross-functional teams including Merchandising, Marketing, and Logistics
4. Government & External Coordination
- Liaise with regulatory authorities regarding submission status, clarification requests, and inspections
- Coordinate with external vendors, suppliers, and logistics partners to ensure documentation completeness
- Support audits and regulatory inspections as required
5. Compliance & Internal Support
- Assist in developing internal compliance guidelines and SOPs
- Support internal training sessions on regulatory requirements
- Maintain compliance tracking reports and dashboards for management review
Qualifications
- Bachelor's degree in Pharmacy, Science, Regulatory Affairs, Law or related fields
- Minimum 5 years of experience in regulatory affairs, product registration, or compliance
- Direct experience working with Thai FDA, OCPB, and relevant regulatory bodies
- Experience in cosmetics, FMCG, or import businesses preferred
- Familiarity with product labeling compliance and import licensing requirements
