Regulatory Affairs Head Singapore

**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** **1\. Regulatory Strategy & Portfolio Leadership** * Develop and execute regulatory strategies across the product lifecycle, including new registrations, indications, renewals, variations, and post-approval changes. * Ensure regulatory strategies support business objectives, patient access, and portfolio expansion. * Anticipate regulatory risks, identify opportunities, and implement mitigation plans. * Align local priorities with regional and global regulatory strategies. **2\. Health Authority & External Engagement** * Establish and maintain credible, trusted relationships with the Health Sciences Authority (HSA). * Lead complex regulatory discussions and negotiations with Health Authorities. * Represent the organization in industry associations, regulatory working groups, and external policy forums. * Monitor and influence evolving regulatory policies that impact the business. **3\. Strategic Business Partnership** * Serve as the primary regulatory advisor to the Country Leadership Team. * Partner closely with Commercial, Medical Affairs, Market Access, Supply Chain, Quality, Pharmacovigilance, and Legal. * Provide strategic regulatory input into portfolio prioritization, launch planning, lifecycle management, and business investment decisions. * Ensure regulatory considerations are integrated early into business planning. **4\. Leadership & Organizational Development** * Lead, develop, and inspire a high-performing Regulatory Affairs organization. * Foster a culture of accountability, collaboration, innovation, and continuous improvement. * Coach and develop future regulatory leaders through effective succession planning. * Allocate resources to ensure delivery of strategic priorities. **5\. Compliance, Governance & Operational Excellence** * Ensure full compliance with Singapore regulatory requirements and internal quality standards. * Maintain robust governance, inspection readiness, and regulatory risk management. * Drive operational excellence through process simplification, digitalization, and continuous improvement. * Lead organizational change initiatives impacting Regulatory Affairs. **Minimum Qualifications** * Bachelor’s degree in Pharmacy, Medicine, Life Sciences or a related scientific discipline. * Minimum 8-10 years of progressive Regulatory Affairs experience within the pharmaceutical industry. * Demonstrated leadership of Regulatory Affairs teams. * Strong knowledge of Singapore regulatory requirements and the Health Sciences Authority (HSA). * Proven experience in regulatory submissions and acceleration, approvals, and lifecycle management .  * Experience working within regional and global matrix organizations   **Skills Desired** Clinical Trials, Cross-Functional Teamwork, Detail-Oriented, Drug Development, Lifesciences (Inactive), Problem Solving Skills (Inactive), Regulatory Compliance, Risk Management