Cluster Head, Medical
2 days ago
Location: Novena Square, SG, SGGlobal Business Unit: HECJob Function: Regulatory ServicesRequisition Number: Description:
Job Summary
The Cluster Head, Medical & Regulatory Affairs, South East Asia (SEA) based in Singapore provides strategic leadership and operational oversight across both Medical and Regulatory Affairs functions in the region. Leading a team of country medical and regulatory heads, the role ensures scientific integrity, medical governance, regulatory compliance, and cross-functional collaboration to support the portfolio across its entire lifecycle.
This position serves as the key interface between global/regional leadership and local country operations, aligning strategies with business priorities while adapting to local market and regulatory environments.
Key Responsibilities
Strategic Leadership
- Define and execute cluster-wide medical and regulatory strategies aligned with overall business objectives.
- Act as a strategic partner to global/regional leaders, contributing to lifecycle planning and business development strategies.
Medical & Regulatory Affairs
- Drive medical excellence across the cluster, ensuring scientific engagement and alignment with therapeutic area strategies.
- Oversee regulatory submissions, registrations, and lifecycle management across SEA markets.
Cross-functional Collaboration
- Partner with commercial, market access, and other cross-functional teams to deliver integrated business planning and execution.
- Provide medical and regulatory insights to support business development and partnership opportunities.
Governance & Compliance
- Establish and maintain robust quality systems and regulatory governance frameworks in line with global risk and compliance standards.
- Monitor regulatory intelligence, adapting strategies proactively to evolving policies and market dynamics.
Talent Development & Leadership
- Coach and mentor country medical and regulatory leaders, building high-performing teams.
- Ensure succession planning, capability development, and a culture of accountability and excellence across the cluster.
External Engagement
- Represent the company in industry associations, regulatory forums, and scientific discussions.
- Build strong relationships with key opinion leaders, regulators, and external partners to shape the external environment and support strategic partnerships.
Education & Experience
- Advanced degree in life sciences (MD, PhD, PharmD, or equivalent) strongly preferred.
- 10+ years of experience in medical affairs and regulatory affairs within the pharmaceutical or biotech industry.
- Proven regional or cross-country leadership experience in a matrixed organization.
- Strong leadership skills with demonstrated success in talent development and team engagement.
- Deep understanding of customer needs, regulatory dynamics, and evolving market environments in SEA.
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