Job Purpose

Lead Vietnam RA for pharmaceuticals and/or health supplements, defining approval pathways, ensuring lifecycle compliance and advising on launch, supply and commercial risks.

Key Responsibilities

Regulatory Strategy & Portfolio Planning

• Assess new product classification, registration pathways, dossier gaps and risks.
• Align annual RA plans, timelines, resources and costs with BU, manufacturers and regional/global RA.

Product Registration & Dossier Quality

• Prepare, review and submit registration/declaration dossiers; resolve gaps and authority queries on time.
• Ensure complete, consistent CPP, CFS, GMP, stability, safety/efficacy, clinical and BE documentation, as applicable.

Lifecycle Maintenance & Post Approval Changes

• Manage authorization validity, renewals, commitments, notifications, variations and new applications.
• Assess site, formulation, process, specification, packaging, shelf-life and product information changes.
• Align implementation and stock transitions with QA, manufacturers and Supply Chain; retain compliance evidence.

Regulatory Intelligence & Implementation

• Monitor regulatory developments, distinguish drafts from issued requirements and assess effective dates and business impacts.
• Advise management, update procedures, train relevant functions and track implementation.
• Provide RA clearance within delegated authority and escalate noncompliance.

Labeling, Product Information & Promotional Compliance

• Check labels, packaging, translations and instructions for required content, warnings and authorized/declared information.
• Review claims and promotions across web, social, e-commerce and video/KOL channels with Marketing, Medical and Legal.
• Verify evidence, permitted content and audiences; manage approvals, versions, updates and corrections.

Launch Readiness & Supply Support

• Confirm launch/import readiness with BU and Supply Chain; provide required regulatory documents.
• Report dossier status, permit issues and manufacturing/import/sales changes; recommend actions to prevent supply disruption.

Authority Engagement, Post Market & Trademark Coordination

• Manage authority correspondence, queries, inspection records, responses and RA corrective actions.
• Coordinate safety reports, product updates, complaints and recalls with QA/PV; handle assigned regulatory communications and route safety information.
• Support trademark records, renewals and issues with Legal, IP advisors and HQ.

Procedures, Regulatory Records & Resource Management

• Maintain SOPs, portfolio/submission records, deadlines, approvals and e-submissions; ensure data integrity, confidentiality and traceability.
• Improve processes based on risks/errors; allocate resources, review dossiers and develop assigned staff where applicable.
• Forecast/control fees, consultancy costs and delegated budgets; monitor providers and report progress, risks and mitigation.

Requirements

Education

• Degree in Pharmacy or a relevant medical/life science discipline.

Experience

• 15–20 years of relevant RA experience, including new registrations for imported and locally manufactured products, renewals and variations.
• Experience working with authorities and leading regulatory projects.

Skills

• Vietnam RA regulations; ACTD/ICH CTD, as applicable.
• Planning, dossier review, risk assessment & problem solving.
• Cross-functional coordination & team development, where applicable.
• Good English for technical documents & global collaboration.
• MS Office, AI tools, document management & e-submission.