Cluster Head, Medical & Regulatory Affairs

DKSH Spain

Not Interested
Bookmark
Report This Job

profile Job Location:

Singapore - Singapore

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

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.
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 scien...
View more view more

Key Skills

  • Proofreading
  • Adobe Acrobat
  • FDA Regulations
  • Manufacturing & Controls
  • Biotechnology
  • Clinical Trials
  • Research & Development
  • GLP
  • cGMP
  • Product Development
  • Chemistry
  • Writing Skills

About Company

Company Logo

DKSH Spain distributes, markets, and sells high-quality products and brands, helping businesses in Spain develop and grow.

View Profile View Profile