EU/ROW Compliance Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Position

We are looking for a highly skilled and experienced Regulatory Affairs professional to join our team as an Associate Director, EU/ROW Regulatory Lead. In this role, you will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, leading the preparation of strategic regulatory documents, and evaluating regulatory risks and recommending mitigation strategies to cross-functional teams and management.

Main Duties and Responsibilities
  • Develop and execute the EU/ROW regulatory strategy for assigned projects.
  • Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.
Required Skills and Qualifications
  • A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
  • 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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