Assistant Regulatory Affairs Manager (Cosmetics & Skincare)

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.