Director of Regulatory Affairs and Strategy Lead

1 month ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a highly experienced Senior Director, Regulatory Affairs Strategy-EU/RoW to join our Global Regulatory Affairs organization.

Key Responsibilities
  • Develop and execute EU/ROW regulatory strategies for assigned programs, aligning with global development and commercial goals.
  • Lead a team of Regulatory Strategists, providing mentorship and guidance to ensure successful project delivery.
  • Cultivate strong relationships with health authorities, representing Regulatory Affairs across Genmab committees as required.
  • Evaluate and mitigate regulatory risks, communicating effectively to senior management.
  • Maintain expertise in EU and MHRA regulations, ensuring compliance and optimal product development.
Requirements
  • Minimum 10 years of experience in Regulatory Affairs, with a proven track record in complex clinical submission strategies.
  • Strong leadership skills, with experience in managing a team of Regulatory Strategists.
  • Expertise in drug development and EU regulatory mechanisms to expedite development.
  • Prior experience leading health authority meetings with the EMA or other health authorities is preferred.
What We Offer
  • An estimated salary of $180,000 per year, reflecting the complexity of the role and the requirements of the position.
  • A dynamic work environment, leveraging agile working practices to support employee well-being and productivity.
  • The opportunity to work on innovative cancer treatments, transforming the lives of patients worldwide.
Why Genmab?
  • Our commitment to excellence, reflected in our rigorous approach to problem-solving and collaboration.
  • A culture that values diversity, inclusivity, and open communication.
  • The chance to contribute to groundbreaking research, driving meaningful change in the field of oncology.

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