Director of Regulatory Strategy for Global Development

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We're seeking a talented and motivated Senior Director to lead our Regulatory Affairs function.

In this role, you'll be responsible for developing global regulatory strategies for our portfolio of development pipeline candidate drugs and marketed products.

You'll provide strategic input and ensure operational execution of global submission activities, including interacting directly with EMA and overseeing regulatory CROs for territories outside Japan and the US.

The chosen candidate will have extensive experience in drug development and EU regulatory mechanisms to expedite development and prior experience leading health authority meetings with EMA or other health authorities.

About Our Team
  • We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
  • Our team is comprised of passionate individuals who genuinely care about our mission to transform the lives of patients through innovative cancer treatment.


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