Associate Director Regulatory Strategy

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

The Associate Director, Global Regulatory Affairs Project Lead will play a critical role in our Global Regulatory Affairs organization. As an expert in regulatory affairs, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.

You will lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc., and plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.

Responsibilities:
  • Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.
  • Lead the preparation of strategic regulatory documents.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.

The chosen candidate may also be allocated as EU/ROW regulatory strategy lead to one or multiple compounds in early development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.



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