Regulatory Affairs Head

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

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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Division

Development

Business Unit

Development

Location

Singapore

Site

Mapletree Business City (MBC)

Company / Legal Entity

SG04 (FCRS = SG004) Novartis Singapore Pte Ltd

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No