ลักษณะงาน
• Prepare registration dossier according to local Regulation and FDA requirement.
• Manage Thai FDA comments along submission process and ensure that products will obtain registration approval as timeline.
• Filing documents for variation amendment.
• Ensure that all key products will be submitted follow strategic plan.
• Liaise with the regulatory authorities to obtain registration certificate approval or amendment approval.
• Ensure that products are complied with the current laws and regulations.
• Support products importation by ensuring that all documents are aligned with local requirements.
• Arrange and update packaging artworks of registered products.
• Others as assigned by supervisor.
ทำงานประจำตึก United Center (BTS ศาลาแดง) จันทร์-ศุกร์ 8.00-17.00
คุณสมบัติผู้สมัคร
1. B.Sc. (Pharmaceutical Science) is required. 2. At least 5 years experiences in regulatory affairs. 3. Responsible, hard-working, well-organized. 4. Good command in English both writing and speaking. 5. Good interpersonal with negotiation skills, decision-making and problem solving.
