Regulatory Affairs Manager
Detail posisi
Kewajiban
• Prepare and submit regulatory documents to the Thai Food and Drug Administration (TFDA) for product registration, variations, and renewals.
• Registration of new products as plan to ensure the launch plan for products portfolio will be as scheduled.
• Responsible for product license renewal, company's license, GMP clearance, amendment and annual report.
• Maintain the registration license up to date throughout the lifecycle of products as required by local regulations.
• Monitor changes in regulatory requirements and ensure company policies and practices remain compliant.
• Conduct internal audits and training programs to ensure adherence to regulatory standards across departments.
• Maintain and manage regulatory files and databases, ensuring all documents are current and accessible.
• Prepare and review labeling and promotional materials for compliance with regulatory standards.
• Coordinate all related responsibilities for Bioavailability(BA)/ Bioequivalent(BE), Clinical study center and regulatory authority.
• Pharmacovigilance coordinator to improve public health and safety in relation to the use of pharmaceutical products.
Kualifikasi
• Bachelor's degree in Pharmaceutical Sciences.
• At least 5-8 years experience in Regulatory Affairs responsible for Pharmaceutical products.
• In-depth knowledge of Thai regulatory processes and international standards.
• Strong analytical, organizational, and project management skills.
• Excellent communication skills in both Thai and English.