หน้าที่ความรับผิดชอบ

• Prepare and submit regulatory documents in compliance with Thai FDA regulations for new product registrations, post-approval variations, and license renewals for pharmaceuticals, veterinary drugs, and human and veterinary vaccines to be imported into Thailand.
• Review and revise artwork proofs and packaging labels to ensure compliance with regulatory requirements.
• Be responsible for pharmacovigilance activities and the preparation and maintenance of SMPC, PIL, and RMP documents in accordance with regulatory requirements.
• Review quality documents to support importation and customs clearance, including Certificates of Analysis (CoA), GMP Certificates, and ISO Certificates, for product release while ensuring compliance with applicable regulations.
• Communicate effectively and professionally with Thai FDA officers to ensure regulatory projects are completed according to the planned timeline.
• Communicate effectively with overseas suppliers in both spoken and written English to achieve project objectives.
• Demonstrate critical thinking, decision-making, and problem-solving skills while working collaboratively with the Regulatory Affairs team and suppliers to complete new product registration projects on schedule.
• Provide scientific and regulatory support to the Sales team.