หน้าที่ความรับผิดชอบ

• Prepare registration dossier according to FDA requirement, the documents for GMP Clearance of Overseas manufacturer and amendment of commercial products. 
• Liaise with the regulatory authorities to obtain registration certificate approval or amendment approval.
• To ensure compliance with other government agency requirements e.g., pharmaco-vigilance and advertisement.
• Co-ordinate with company agents in other countries and contact manufacturers to ensure that the registration dossier, packaging artworks meet the requirements of each country, and the regulatory issues properly manage and resolved.
• Responsible for all assigned Regulatory Affairs activities and relevant activities i.e., GDP.