หน้าที่ความรับผิดชอบ

• Manage all activities pertaining to product registration and other regulatory approvals, including registration plans and submission strategies, product advertising, product reports, and company license renewals.
• Complete all documentation for drug, medical devices and cosmetics to be filed and registered mainly at Thai FDA.
• Partner with team members (i.e. RA, QA, Marketing, Supply chain, etc) to manage the product to be valid with compliance to local regulation (i.e. variation/renewal/GMP clearance submission and approval)
• Providing support in terms of product importation, prepare all concerned documents to be completed and ready to be submitted for FDA’s consideration i.e. Application form,GMP certificate, COA, COO, Product specification sheet, Certificate of manufacturer, Import license, Labelby ensuring that all documents are aligned with local requirements.
• Candidates should be able to communicate in English with international colleagues for the exchange of information regarding regulatory affairs. Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
• Candidates should be able to review and identify impacts from new regulatory guidelines and regulatory trends, monitor changes in regulations, and consider all proper measures needed to complete tasks.