Regulatory Affairs Head Singapore

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Job Description 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 Job Description 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 Skills Desired Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management

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