REQ-10080728
Jun 12, 2026
Singapore
Summary
Provide strategic leadership of Regulatory Affairs at the country level, driving the development and execution of forward-looking regulatory strategies that ensure timely approvals, sustained compliance, and accelerated patient access.
Act as a key business partner and member of the country leadership team, shaping decisions through proactive regulatory insights, risk anticipation, and solution-oriented thinking. Lead efforts to influence the external regulatory environment by building strong Health Authority partnerships and contributing to policy evolution that supports innovation and access to medicines.
Champion a high-performance regulatory organization that balances operational excellence with strategic agility, leveraging digital tools, data, and regulatory intelligence to enhance efficiency, transparency, and decision-making. Ultimately, enable sustainable business growth and maximize portfolio value by embedding regulatory strategy at the core of business planning and execution
Act as a key business partner and member of the country leadership team, shaping decisions through proactive regulatory insights, risk anticipation, and solution-oriented thinking. Lead efforts to influence the external regulatory environment by building strong Health Authority partnerships and contributing to policy evolution that supports innovation and access to medicines.
Champion a high-performance regulatory organization that balances operational excellence with strategic agility, leveraging digital tools, data, and regulatory intelligence to enhance efficiency, transparency, and decision-making. Ultimately, enable sustainable business growth and maximize portfolio value by embedding regulatory strategy at the core of business planning and execution
About the Role
Key Accountabilities:
- Lead and define the country regulatory strategy aligned with global and regional objectives to ensure timely approvals and sustainable market access.
- Oversee end-to-end regulatory activities across the portfolio (development, registration, lifecycle management), ensuring full compliance with local health authority requirements.
- Act as the primary interface with Health Authorities, building strong, credible relationships to shape regulatory outcomes and influence policy where appropriate.
- Ensure regulatory compliance and governance, including adherence to internal policies, quality standards, and evolving local regulations.
- Provide strategic input to cross-functional teams (Medical, Market Access, Commercial, Development) to optimize submission strategies and maximize product value.
- Lead, coach, and develop the local RA team, building capabilities, ensuring talent growth, and fostering a high-performance and compliant culture.
- Drive regulatory intelligence and policy awareness, anticipating changes in the regulatory landscape and translating them into actionable strategies.
- Ensure timely and high-quality submissions and approvals, proactively identifying risks, resolving issues, and accelerating timelines wherever possible.
- Represent Regulatory Affairs in country leadership teams, contributing to business decisions and ensuring regulatory perspectives are embedded early.
- Champion digitalization and process excellence in RA, leveraging tools and data to enhance efficiency, transparency, and decision-making.
Minimum Requirements:
- Proven regulatory leadership experience within the pharmaceutical industry, spanning 8–10 years
- Expertise in end-to-end regulatory portfolio management, including innovative and complex product pipelines
- Strong track record of engagement with global Health Authorities, driving successful regulatory outcomes
- Demonstrated leadership in building, mentoring, and strengthening high-performing teams
- Solid experience in operations management, ensuring effective execution and delivery of regulatory objectives
- Experienced in leading organizational restructuring and driving change management initiatives
- Recognized contribution to policy development and shaping of regulatory frameworks
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Development
Development
Singapore
Mapletree Business City (MBC)
SG04 (FCRS = SG004) Novartis Singapore Pte Ltd
Research & Development
Full time
Regular
No
