Director of EU Regulatory Compliance

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Job

This is an exciting opportunity to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. As a key member of our team, you will play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial submission activities.

Key Responsibilities:

  • Develop and execute the EU/ROW regulatory strategy for assigned projects
  • Represent RA on Clinical Trial Teams and ensure regulatory oversight of clinical trial submission activities
  • Evaluate competitive landscape and various regulatory mechanisms to optimize product development
  • Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, PRIME, etc.
  • Plan, prepare, and lead EU and national Scientific Advice procedures as relevant
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
  • Maintain up-to-date knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working

Requirements:

  • A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred
  • Minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase
  • Significant experience in proactively planning and executing highly complex clinical submission strategies
  • Solid understanding of drug development and EU regulatory mechanisms to expedite development
  • Prior experience leading health authority meetings with EMA or other health authorities, as well as experience with PIPs
  • Strong project management skills

About Us

  • We are a passionate team dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics
  • We believe in the power of collaboration and teamwork to achieve our goals
  • We are committed to fostering a culture of innovation, creativity, and continuous learning


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