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As an Associate Director, Global Regulatory Affairs Project Lead at Genmab, you will play a key role in ensuring the successful execution of clinical trials in the EU and ROW regions. In this position, you will be responsible for representing RA in the Clinical Trial Teams and working closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions.

About the Role

You will act as EU/ROW regulatory lead for assigned projects and be responsible for developing and executing EU/ROW strategies. You will also lead the preparation of strategic regulatory documents, such as briefing packages, ODDs, PIPs, etc. and 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 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.