Global Regulatory Affairs Project Lead

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Overview

We are seeking a highly skilled and experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. In this role, 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 work closely with the CRO and internal stakeholders to develop and execute EU/ROW regulatory strategies for assigned projects. This position requires strong project management skills, excellent communication and time management abilities, as well as a good understanding of drug development and EU regulatory procedures.

Key Responsibilities:
  • Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.
  • Develop and execute EU/ROW regulatory strategies for assigned projects.
  • Work closely with the CRO and internal stakeholders to ensure successful execution of clinical trial submissions.

This role is located in Copenhagen, Denmark and is hybrid, which means on-site presence 60% of the time.



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