Regulatory Affairs Manager (Hanoi)

About the job

This position is based in Hanoi, Vietnam, and is responsible for leading the local Regulatory Affairs strategy, overseeing the execution of all regulatory activities, and managing interactions with Global Regulatory Teams and head-office-based business units. The RA Manager will drive the regulatory agenda for Vietnam, ensuring alignment between global corporate objectives and local commercial goals while ensuring 100% compliance with local regulations.

Primary Responsibilities

• Define and execute long-term regulatory strategies aligned with corporate commercial objectives and broader market expansion frameworks.

• Provide early-stage regulatory input to shape localization, commercialization, and portfolio launch readiness.

• Map out proactive risk-mitigation pathways to anticipate shifting legislative landscapes and accelerate time-to-market metrics.

• Serve as the core subject matter expert (SME) to senior leadership regarding the evolution of local healthcare policies.

• Oversee the full lifecycle of the regulatory portfolio, including: New product registrations (pharma, biosimilars, controlled substances); Variations, renewals, transfers, and divestments

• Ensure continuous supply by proactively managing regulatory timelines and risks

• Drive optimization of submission processes and dossier quality standard.

• Lead and ensure high-quality and compliant submissions (CTD/eCTD where applicable)

• Oversee GMP accreditation; Bioequivalence (BE) studies and biowaivers; Coordination of local clinical/BE studies

• Implement best practices and continuous improvement initiatives in regulatory processes

• Build and maintain high-level relationships with: Vietnam Health Authorities (DAV, MOH); Key opinion regulators and external stakeholders;

• Act as the primary local escalation lead for high-complexity regulatory inquiries.

• Partner seamlessly with Global Regulatory, Quality Systems, Safety, and Commercial business units to guarantee business continuity

• Spearhead preparation and support for internal and external organizational audits

• Provide leadership, coaching, and strategic direction to the local compliance/regulatory function

• Establish clear performance indicators, foster key capabilities, and cultivate a culture of accountability and resilience

Qualifications & Requirements

• Education: Bachelor’s degree in Pharmacy (compulsory). Post-graduate degree in a related field is a plus.

• Experience: 8+ years of progressive experience in regulatory affairs within the pharmaceutical industry, with at least 2–3 years in a senior, lead, or managerial capacity dealing directly with the DAV.

• Language: Professional fluency in English and Vietnamese (both written and spoken) is required for high-level negotiations and global reporting.

• Legal Compliance: Not disbarred or restricted from pharmaceutical operations by any regulatory authority.

Key Capabilities & Competencies

• Strategic Regulatory Vision: Proven ability to translate complex regulatory frameworks into actionable, competitive business advantages.

• Advanced Negotiation & Stakeholder Management: Exceptional capability to influence, persuade, and negotiate effectively with both internal global executives and external Health Authority officials.

• Project & Portfolio Management: Strong track record of managing multiple complex projects simultaneously under tight commercial deadlines.

• Analytical Thinking & Crisis Management: Highly developed problem-solving skills with the ability to navigate ambiguous regulatory environments and resolve critical compliance issues rapidly.

• Leadership & People Development: Demonstrated ability to guide, motivate, and elevate team members or cross-functional peers.

To apply, please send your updated CV to Dang Le at [email protected] , quoting the job title or Click Apply Now. Due to an anticipated high volume of applicants, we regret that only shortlisted candidates will be notified.