Regulatory Affairs and Quality Specialist
Job Description
About the Role:
Key Responsibilities
Quality Assurance & Control
• Develop, implement, and maintain Quality Management Systems (QMS) for cosmetics and supplements.
• Ensure compliance with GMP for cosmetics and dietary supplements, including Thai FDA requirements and relevant ISO standards.
• Review and approve raw materials, packaging materials, artwork, finished goods, and vendor documentation.
• Conduct internal audits, supplier audits, and support third-party audits.
• Investigate quality deviations, customer complaints, and CAPA processes.
Regulatory Compliance
• Ensure compliance with Thai regulatory bodies and requirements, including:
- Thai FDA (Food and Drug Administration)
- Ministry of Public Health (MOPH) notifications
- ASEAN Cosmetic Directive (ACD)
- TISI standards where applicable
• Manage product notifications, registrations, licenses, renewals, and regulatory submissions for cosmetics and dietary supplements.
• Review product formulations, labeling, claims, and marketing materials to ensure adherence to Thai and ASEAN regulations.
• Monitor and interpret regulatory changes within Thailand and the broader SEA region.
Supplier & Manufacturing Oversight
• Qualify and manage contract manufacturers and suppliers in Thailand and the SEA region.
• Ensure manufacturing processes meet required quality and regulatory standards.
• Support technology transfer, scale-up, pilot production, and commercialization activities.
Documentation & Reporting
• Maintain accurate SOPs, specifications, COAs, batch records, and regulatory documentation.
• Prepare quality and regulatory reports for internal stakeholders and regulatory authorities.
• Support inspections by Thai FDA, certification bodies, and external auditors.
Cross-Functional Collaboration
• Work closely with R&D, Procurement, Manufacturing, Operations, Marketing, and Legal teams.
• Provide quality and regulatory guidance from product concept through commercialization.
Qualifications & Experience
• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or related field.
• 5–8 years of experience in Quality Assurance and/or Regulatory roles within cosmetics and/or dietary supplements.
• Strong working knowledge of Thai FDA regulations, MOPH notifications, and ASEAN Cosmetic Directive requirements.
• Experience working with third-party manufacturers and suppliers.
• Knowledge of international regulatory standards (e.g., US FDA, EU Cosmetic Regulation) is an advantage.
Key Skills & Competencies
• Strong understanding of Thai and ASEAN cosmetic & supplement regulatory frameworks.
• Proficiency in audit management and CAPA processes.
• Excellent documentation accuracy and analytical skills.
• Ability to interpret regulations and translate them into practical business actions.
• Strong communication and stakeholder management abilities.
• Exceptional attention to detail and a proactive problem-solving mindset.
Preferred Attributes
• Experience launching products in the Thailand market.
• Exposure to both cosmetics and dietary supplement categories.
• Experience in multinational, fast-growing, or startup environments.