Regulatory Affairs Manager (Imported Drugs)

1.1. Managing & Coordinating Imported Drug Registration
Build and implement annual registration plans specifically for imported pharmaceuticals.
Manage, assign tasks, and supervise the preparation and submission of registration dossiers for imported drugs.
Review, evaluate, and approve dossiers before submitting to the Drug Administration of Vietnam (DAV) and other authorities.
Update and communicate regulatory changes related to imported pharmaceuticals, variations, renewals, and import licensing processes.
1.2. Reviewing & Controlling Imported Drug Dossiers
Assess dossier quality to ensure full compliance with MOH regulations and guidelines for imported drugs.
Work closely with foreign manufacturers/partners to obtain, standardize, and finalize technical documents (CTD format, GMP, CPP, LOA, etc.).
Coordinate with internal departments (QA, QC, PV, Warehouse, Supply Chain...) to ensure documentation meets regulatory requirements.
Review documents related to product quality, stability data, manufacturing processes, and foreign regulatory certificates.
1.3. Acting as a Regulatory Liaison
Represent the company in working with DAV, local health authorities, and inspection bodies on imported drug matters.
Track dossier evaluation progress, respond to official letters, and manage additional requests from authorities.
Work with foreign partners to resolve regulatory issues, update technical documentation, and ensure timely approval.
1.4. Personnel Management & Training
Manage and supervise the RA team, including performance evaluation and daily task coordination.
Train staff on regulations for imported drug registration, documentation standards, and communication with foreign partners.
Develop internal procedures to enhance compliance and dossier preparation efficiency.
1.5. Reporting & Compliance Improvement
Prepare regular reports on registration status for imported products and present to the Board of Directors.
Propose improvements to optimize the imported drug registration process and minimize regulatory risks.
Support compliance activities related to imported drugs, such as post-approval changes and license renewals.