EU/ROW Regulatory Strategy Director

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Role

As a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will join our Global Regulatory Affairs organization and assume responsibility for EU/ROW regulatory strategy for assigned program. You will manage a group of Regulatory Strategists with EU/ROW responsibilities for Genmab's programs across all stages of development.

The successful candidate will have a strong background in Regulatory Affairs, with a minimum of 10 years of experience across all development phases. They will possess expertise in drug development and EU regulatory mechanisms to expedite development, as well as experience leading health authority meetings with the EMA or other health authorities.

You will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products, and for ensuring compliance with all internal and external requirements and procedures related to Regulatory Affairs.

Requirements:

  • A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. PhD or MD degree preferred.
  • Minimum of 10 years of experience in Regulatory Affairs, across all development phases.
  • Significant experience in proactively planning and implementing highly complex clinical submission strategies.
  • Experience in leading a team of regulatory strategist professionals.
  • Expertise in drug development and EU regulatory mechanisms to expedite development.
  • Experience within oncology preferred.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • Experience with submitting and bring to completion MAAs in Europe/ROW.
  • Experience with variation procedures.


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