Genmab

Senior Director, Global Regulatory Affairs, Team Lead, Strategy (Europe & RoW)

Genmab(2 months ago)

HybridFull TimeDirector$197,688 - $261,899 (estimated)Regulatory Affairs
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About this role

Senior Director within Genmab’s Global Regulatory Affairs organization responsible for leading Europe/Rest of World regulatory strategy for assigned antibody development and marketed products. The role serves as a senior leader and primary EMA contact for portfolio programs, mentoring a team of Regulatory Strategists and ensuring regional strategies align with global development and commercial objectives. This position reports to the Head of Regulatory Affairs and supports cross-functional, global program coordination.

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Required Skills

  • Regulatory Strategy
  • EMA Interactions
  • Health Authorities
  • Clinical Submissions
  • MAA Submissions
  • Project Management
  • Team Leadership
  • CRO Oversight
  • CMC Changes
  • Labeling Review

+2 more

Qualifications

  • Bachelor's Degree in Scientific Discipline
  • PhD
  • MD
Genmab

About Genmab

genmab.com

Genmab is an international biotech company specializing in antibody therapeutics for the treatment of cancer and other serious diseases

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