หน้าที่ความรับผิดชอบ

• Manage all activities related to product commercialization for pharmaceutical products, medical devices and biologics (from import, production, clinical trials, to registration)
• Review and evaluate product documentation, along with coordination for any additional documents, clarifications, samples, etc. as required for GMP certification and product registration
• Identify potential paths to registration, risks, and potential mitigations for technologies under evaluation
• Ensure that all practices comply with the laws, guidelines, regulations and practices in Thailand
• Provide input and advance notification on potential regulatory and quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations
• Maintain high level regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain
• Manage and coordinate all relevant pharmacovigilance activities for the products
according to Thai FDA regulations
• Ensure documentation of the registered products
• Perform all other duties assigned by management
• Maintain excellent working relationship with Thai FDA and governing bodies
• Maintain excellent working relationship with academic institutions, companies, and other entities that Company works with
• Able to discuss with all Thai parties on Company’s behalf