Director of Regulatory Affairs and Project Leadership

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Role Overview

We are seeking a highly skilled and experienced professional to join our Global Regulatory Affairs organization as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW.

You will be responsible for representing EU/ROW in the Global Regulatory Team(s), acting as EU/ROW regulatory lead for assigned projects, and leading the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc. Additionally, you will plan, prepare, and lead EMA or national Scientific Advice procedures as relevant, evaluate regulatory risks, and recommend mitigation strategies to cross-functional teams and management.

Key Responsibilities
  • Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  • Represent EU/ROW in the Global Regulatory Team(s).
  • Act as EU/ROW regulatory lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
  • Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
  • Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.


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