Regulatory Affairs Team Leader

1. Managing & Coordinating Drug Registration Activities
Develop the annual regulatory registration plan for both domestic and export markets.
Manage, assign tasks, and monitor the progress of registration dossiers in compliance with MOH regulations and specific requirements of export markets.
Guide, review, and approve registration dossiers before submission to local and foreign authorities.
Update and disseminate regulatory requirements related to drug registration, variations, renewals, export, and import activities.
2. Reviewing & Controlling Registration Dossiers
Check and evaluate the quality of registration dossiers to ensure full compliance with Vietnam's regulations and those of export markets.
Coordinate with internal departments (R&D, QA, QC, Production, Sales, etc.) to standardize documentation.
Work with overseas partners to prepare dossiers for export drug registration.
Review and verify documents related to technology transfer, contract manufacturing, and production processes for different markets.
3. Liaising with Regulatory Authorities & Partners
Represent the company when working with the Drug Administration of Vietnam (DAV), local health authorities, and foreign regulatory bodies.
Monitor dossier evaluation progress, respond to queries, and handle additional requests from authorities.
Coordinate with domestic and international manufacturers/partners to ensure timely dossier approval.
4. Personnel Management
Manage, train, and evaluate the RA team.
Develop and optimize internal RA procedures to improve operational efficiency.
Provide training on domestic and export drug registration regulations and documentation requirements.
5. Reporting & Process Improvement
Prepare periodic reports on domestic and export registration progress for the Board of Directors.
Propose improvements and strategic directions to enhance the efficiency of registration activities and new product submissions.