Regulatory Affairs Manager (Imported Drugs)

Managing & Coordinating Imported Drug Registration

Review, evaluate, and approve dossiers before submitting to the Drug Administration of Vietnam (DAV) and other authorities.
Build and implement annual registration plans specifically for imported pharmaceuticals.
Update and communicate regulatory changes related to imported pharmaceuticals, variations, renewals, and import licensing processes.
Manage, assign tasks, and supervise the preparation and submission of registration dossiers for imported drugs.

Reviewing & Controlling Imported Drug Dossiers

Review documents related to product quality, stability data, manufacturing processes, and foreign regulatory certificates.
Coordinate with internal departments (QA, QC, PV, Warehouse, Supply Chain…) to ensure documentation meets regulatory requirements.
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.).

Acting as a Regulatory Liaison

Track dossier evaluation progress, respond to official letters, and manage additional requests from authorities.
Represent the company in working with DAV, local health authorities, and inspection bodies on imported drug matters.
Work with foreign partners to resolve regulatory issues, update technical documentation, and ensure timely approval.

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.

Reporting & Compliance Improvement

Support compliance activities related to imported drugs, such as post- approval changes and license renewals.
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.

Strong understanding of MOH regulations, DAV guidelines, import licensing, variations, and renewal procedures for imported pharmaceuticals.
Strong leadership, communication, and problem- solving skills.
Minimum 5 years of experience in Regulatory Affairs, hands- on experience in imported drug registration in Vietnam.
Bachelor’s Degree in Pharmacy
Fluent in English (technical documentation & communication with foreign partners).
Experience working directly with foreign manufacturers, principals, or licensors.
High sense of responsibility, attention to detail, and ability to work under pressure.

Teambuilding activities, annual company trip, birthday gifts, and other company benefits.
Lunch allowance; company- provided working devices.
Professional environment with opportunities to work directly with international partners.
Full insurance package (Social, Health, Unemployment Insurance).
Competitive salary + performance bonus.
Clear career path

Cập nhật gần nhất lúc: 2026-04-04 13:20:03