Regulatory Affairs Head, Vietnam
Novartis View all jobs
- Vietnam
- Permanent
- Full-time
Location: Hanoi & Ho Chi Minh, Vietnam #LI-HybridThis role is based in Hanoi, Vietnam (preferred location) but also open for Ho Chi Minh. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.To act as the local Regulatory Affairs Head on behalf of Novartis, ensuring timely, compliant approvals from the Ministry of Health (MoH) and Drug Administration of Vietnam (DAV). The role is accountable for defining and executing regulatory strategies that enable competitive advantage, supply continuity, lifecycle optimization, and sustainable business growth across the full product portfolio in Vietnam.Job DescriptionKey ResponsibilitiesStrategic & External Leadership
- Build and maintain strong relationships internally across Therapeutic Areas and functions, and externally with DAV, MoH, and key stakeholders to influence and manage regulatory and legislative changes.
- Develop and execute best-in-class Regulatory Affairs strategies to achieve accelerated approval timelines and optimal labeling outcomes. Monitor, anticipate, and communicate regulatory changes, ensuring alignment with local, Regional, and Global RA teams.
- Represent Novartis in regulatory interactions and ensure outcomes are clearly documented, communicated, and escalated.
- Be accountable for all regulatory and legislative aspects of the product portfolio in compliance with Vietnam regulations and Novartis policies. Lead lifecycle maintenance activities including site transfers, variations, renewals, labeling changes, and post-approval commitments, etc,,, to ensure uninterrupted supply.
- Ensure proactive regulatory planning to minimize risk and prevent supply disruption. Oversee all RA workload to ensure high-quality, compliant files, timely submissions and approvals.
- Collaborate cross-functionally with Commercial, Medical, Quality, Supply Chain, Legal, and Regional/Global teams to ensure alignment on priorities and objectives.
- Act as the central RA contact point between local, Regional, and Global stakeholders. Ensure regulatory strategies support launch readiness, supply resilience, country growth plan and portfolio value.
- Lead the Regulatory Affairs function, providing clear direction and governance. Recruit, coach, and develop a high-performing, engaged regulatory team.
- Drive efficient team performance, optimal resource utilization, and sustainable delivery. Continuously enhance regulatory operational excellence and capability.