Title:  Cluster Head, Medical & Regulatory Affairs

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.