Cluster Head, Medical & Regulatory Affairs

DKSH Holding Ltd; Singapore; On-site; SGD 120,000 - 150,000; Full time

Job summary

A global business services provider based in Singapore is seeking a Cluster Head for Medical & Regulatory Affairs to lead strategic initiatives and operational oversight across Southeast Asia. The ideal candidate will have over 10 years of experience in regulatory and medical affairs within the pharmaceutical industry, strong leadership capabilities, and a proven track record of cross-country team engagement. This position offers a challenging role with a focus on governance and compliance, as well as external engagement with key stakeholders.

Qualifications

• 10+ years of experience in medical affairs and regulatory affairs within the pharmaceutical or biotech industry.
• Proven regional or cross-country leadership experience.
• Strong leadership skills with demonstrated success in talent development.

Responsibilities

• Define and execute cluster-wide medical and regulatory strategies.
• Oversee regulatory submissions and lifecycle management across SEA markets.
• Build strong relationships with key opinion leaders and external partners.

Skills

Strategic planning

Leadership

Regulatory compliance

Cross-functional collaboration

Medical expertise

Education

Advanced degree in life sciences

Job description

Location: Novena Square, SG, SGGlobal Business Unit: HECJob Function: Regulatory ServicesRequisition Number: 193090Description:

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.

Requisition Number: 193090Job Function: Regulatory Services