หน้าที่ความรับผิดชอบ

• Prepare, submit, and follow up on product registration dossiers for New Drugs, Generics, and New Generics to local and international regulatory authorities (e.g., FDA, ICH) in line with the registration plan

• Ensure all submissions and product documentation comply with applicable regulatory requirements and guidelines

• Manage product lifecycle activities, including license renewals, variations, and post-approval changes

• Compile and review technical documents such as CMC (Chemistry, Manufacturing, and Controls), clinical data, and product labeling

• Coordinate with cross-functional teams (R&D, QA, Manufacturing, Supply Chain) to obtain required data for regulatory submissions

• Review and approve packaging artwork to ensure regulatory compliance

• Provide regulatory support to internal departments by addressing inquiries and resolving regulatory-related issues

• Monitor regulatory changes and communicate updates to relevant stakeholders

• Oversee product compliance in the market, including handling adverse events and product complaints reporting

• Support and ensure compliance with company quality systems and standards (e.g., GMP, GDP, ISO 13485, ISO 14001,ISO 9001)