EU Regulatory Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

As a Regulatory Affairs Director EU/ROW Lead at Genmab A/S, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.

About the Role

This is a key member position within the Global Regulatory Affairs organization at Genmab A/S.

  • Key Accountabilities:
  • Act as EU/ROW Regulatory Lead for assigned projects.
  • Develop and execute EU/ROW regulatory strategies.
  • Ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  • Lead the preparation of strategic regulatory documents.

What We Are Looking For:

  • Minimum of 8 years of experience in Regulatory Affairs.
  • Proven track record of developing and executing regulatory strategies.
  • Excellent project management skills.
  • Prior experience leading health authority meetings.


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