Regulatory Affairs Consultant Vietnam

About the Role:

We are a global biopharmaceutical company expanding our product pipeline into the Vietnamese market. We are seeking a highly experienced and well-connected Vietnam Regulatory Affairs Consultant to oversee and accelerate our product registration process in Vietnam. This role will be responsible for end-to-end regulatory strategy, high-quality dossier review, agency interactions, and driving registration milestones through strong local authority network.

Key Responsibilities:

1. Regulatory Intelligence & Monitoring :Continuously monitor and monthly updates guidelines, and policy shifts from the Drug Administration of Vietnam (DAV) / Ministry of Health (MOH).
2. Provide strategic regulatory advice to headquarters:Regarding product classification, dossier requirements, and potential regulatory risks.
3. Dossier Review & Quality Control:Thoroughly review registration dossiers (ACTD/ICH-CTD format) provided by HQ to ensure strict alignment with Vietnamese regulatory standards.Identify gaps in technical/clinical documentation and issue professional rectification requirements/gap analyses to HQ's RA teams before official submission.
4. Submission & Lifecycle Management:Format, compile, and submit registration dossiers to DAV in full compliance with local regulatory requirement within the stipulated time .Closely monitor registration evaluation process, managing official communication, handling Official Deficiency Letters (Deficiency/Query responses), and facilitating Official GMP inspections where applicable.
5. Government Relations & Fast-Track Approval :Leverage strong local networks and contacts within DAV / EDA / MOH to expedite dossier screening, evaluation, and approval processes. Proactively explore and secure opportunities for fast-track channels, priority reviews, or special approval pathways for company pipeline products.Act as the company's primary liaison to navigate administrative bottlenecks and build constructive relationships with local authorities.

Job Requirements & Qualifications:

1. Education & Background: Bachelor's degree or higher in Pharmacy, Pharmacology, Medicine, Chemistry, or related Life Sciences disciplines.
2. Professional Experience: 8+ years of hands-on experience in pharmaceutical Regulatory Affairs in Vietnam, with a proven track record of successful drug registrations (Generic drug or Biosimilars).
3. Solid understanding of Vietnam registration and GMP requirements : DAV submission procedures, local GMP audit , and post-approval variations.
4. Government Relations & Network: Extensive and verifiable contacts/networks within DAV, MOH, and relevant expert committees in Vietnam.Demonstrated capability in accelerating registration timelines and resolving complex regulatory bottlenecks through government relations.
5. Project Management & Communication: Excellent project management skills with high accountability for project milestones and deadlines.
6. Language:Fluent in Vietnamese and English (working proficiency for HQ cross). Proficiency in Chinese is a strong plus.