Regulatory Affairs and Quality Specialist

Bangkok - Thailand

Monthly Salary: Not Disclosed

Posted on: 12 days ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors or Masters degree in Pharmacy Chemistry Microbiology Biotechnology or related field.

58 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.

Required Experience:

About the Role: Key ResponsibilitiesQuality 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 appro...