หน้าที่ความรับผิดชอบ

• Prepare and submitting of ACTD dossier for new drug, new generic drug. Support oversea partners to acquire and prepare ACTD.
• Prepare and submitting of CSDT for complicated medical device. Support oversea partner for documents preparation.
• Prepare a report of product registration status, problem, suggest solution and action plan to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Provide regulatory guidance to related departments, project developing teams regarding design, development and marketing of products.

• Supported related department to prepare label, package insert, patient insert leaflet, promotional material.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Prepare risk management plan, implement and follow up
• Develop local RA staff, document system and maintain standard operating procedures.