หน้าที่ความรับผิดชอบ

• Prepare and submit registration dossiers for New drug, New-generic drugs, and generic drugs to local and international regulatory authorities (e.g., FDA, ICH).
• Ensure all submissions comply with applicable regulatory requirements and guidelines.
• Compile technical documents, including CMC (Chemistry, Manufacturing, and Controls), clinical trial data, and product labeling.
• Stay updated on changes to regulatory requirements and communicate updates to internal teams.
• Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary data for regulatory submissions.
• Manage product license renewals, variations, and post-approval changes to maintain compliance.
• Monitor product performance in the market and report adverse events or product complaints as per regulatory requirements.
• Collaborate with internal teams to ensure alignment on regulatory requirements and timeline.