Regulatory Affairs Head Singapore

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: