Regulatory Affairs and Quality Specialist

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.