• Ensure regulatory compliance of products with Thai FDA (TFDA) requirements for registration, importation, labeling, and post-marketing surveillance across pharmaceuticals, medical devices, or diagnostics.

• Prepare, compile, and submit product registration dossiers (eCTD or local format) in accordance with ASEAN CTD guidelines and other applicable regulations.

• Act as the key contact with the Thai FDA, Ministry of Public Health, and other regulatory bodies to facilitate product approvals, renewals, and audits.

• Monitor local and international regulatory updates (e.g., ASEAN, WHO, ICH) and advise internal stakeholders on regulatory strategy, risk, and impact on business operations.

• Collaborate with cross-functional teams (QA, R&D, marketing, supply chain) to support product lifecycle management, change control, and regulatory labeling compliance.

Please apply through admin@managray.com