Regulatory Compliance Specialist

• To lead and manage regulatory compliance, ensuring the company operates in full alignment with applicable laws, standards, and internal policies. This role oversees PDPA, ISO standards, FDA audits, and import/export regulations while driving continuous improvement and risk mitigation across the organization.

• Manage company regulatory information and ensure accuracy, completeness, and timely updates.

• Monitor regulatory changes and assess potential impact on business operations.

• Strengthen organizational standards through audits and regulatory excellence.

• Ensure compliance with Personal Data Protection Act (PDPA) in all business operations.

• Provide guidance to internal stakeholders on data privacy and protection requirements.

• Develop and maintain policies, procedures, and controls related to data protection.

• Support PDPA audits, risk assessments, and incident handling.

• Support implementation and maintenance of ISO standards (e.g., ISO 9001).

• Ensure processes align with quality management and continuous improvement principles.

• Coordinate internal and external ISO audits and ensure audit readiness.

• Drive corrective and preventive actions (CAPA) from audit findings

• Lead and support FDA audits and regulatory inspections.

• Act as the main contact point with regulatory authorities during audits.

• Ensure readiness of documentation, processes, and compliance systems.

• Track and resolve audit findings and ensure timely closure

• Ensure compliance with import/export regulations and customs requirements.

• Review and verify documentation for import/export activities.

• Coordinate with customs brokers, logistics providers, and authorities.

• Monitor regulatory requirements for non-FDA and FDA-related products.

• Resolve issues related to customs clearance, delays, or non-compliance.

• Drive compliance and risk management initiatives across the organization.

• Identify gaps and implement process improvements to enhance efficiency.

• Maintain proper documentation and records for audit and compliance purposes.

• Collaborate with cross-functional teams (HR, Legal, PD, R&D, PUR, QA, Supply Chain, Logistics, IT, Facility, WH)

• Full compliance with legal, regulatory, PDPA, ISO, and FDA requirements.

• Successful audit outcomes (FDA, ISO, internal & external audits).

• Timely and accurate regulatory reporting to top management.

• Effective risk mitigation and zero major compliance violations

• Bachelor's degree or higher in Law, Business Administration, Economics, or other related field.

• Good command both of Thai and English.

• Good knowledge of the legal system and government bodies in Thailand and the main laws.

• Must be independent, self-motivated and responsive.

Manpower