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Global Regulatory Affairs Project Lead

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, our mission is to develop innovative antibody therapies that change the lives of patients. We are committed to excellence in all aspects of our work, including regulatory affairs.

The Role

We are seeking an Associate Director, Global Regulatory Affairs Project Lead, to join our team. In this role, you will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in the EU and ROW regions. You will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure smooth regulatory processes.

Key Responsibilities:

  • Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple clinical trial submission activities.
  • Act as EU/ROW regulatory lead for assigned projects and be responsible for developing and executing EU/ROW strategies.
  • 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.
  • Maintain knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes.

Requirements:

  • A minimum of a Bachelor's degree or equivalent in a scientific discipline or health-related field. A Master's degree is preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
  • Experience in proactively planning and executing complex clinical submission strategies.
  • A good understanding of drug development and EU regulatory procedures.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • Strong project management skills.