Associate Director of Clinical Trials

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Job

We are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple, often highly complex, clinical trial submission activities.

Responsibilities

  • Ensure regulatory compliance and quality in all aspects of clinical trials.
  • Develop and execute EU/ROW regulatory strategies for assigned projects.
  • Prepare and submit regulatory documents, such as Briefing Packages, ODDs, and PIPs.
  • Collaborate with cross-functional teams to ensure alignment and effective communication.

Requirements

  • A minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
  • Experience in proactively planning and executing highly complex clinical submission strategies.
  • Prior experience leading health authority meetings with the EMA or other health authorities.


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