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