Regulatory Affairs Head Singapore

Novartis

Mapletree Business City (MBC)Posted about 1 month agoDiscoveredMatch locked

Full time

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

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

Not included in the source posting: about the role, what you'll do, benefits.

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