Global Regulatory Affairs Strategic Lead

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we are dedicated to pioneering therapies that transform the lives of patients and redefine cancer treatment. Our team is driven by a shared passion for innovation, excellence, and customer-centricity.

About the Role

We are seeking an experienced Senior Director to lead our Global Regulatory Affairs organization. As a key member of our leadership team, you will develop and execute global strategies to advance our portfolio of development pipeline candidate drugs and marketed products. Your expertise in regulatory affairs will ensure seamless execution of global submission activities, with a strong focus on operational efficiency and compliance.

Your Key Responsibilities
  • Develop and implement global regulatory strategies for assigned projects, aligning with our global development and commercial goals.
  • Lead or be responsible for planning and implementing regional regulatory procedures, including clinical trial applications, marketing applications, label extensions, CMC changes, and PIPs.
  • Represent Regulatory Affairs across Genmab committees as indicated, ensuring effective communication and collaboration with cross-functional teams.
  • Proactively evaluate and communicate regulatory risks and challenges to senior management, providing mitigation options and recommendations.
Requirements

To succeed in this role, you will require:

  • A minimum of 10 years of experience in Regulatory Affairs, across all development phases.
  • Significant experience in proactively planning and implementing complex clinical submission strategies.
  • Experience leading a team of regulatory strategist professionals.
  • Expertise in drug development and EU regulatory mechanisms to expedite development.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • Experience submitting and bringing to completion Marketing Authorization Applications (MAAs) in Europe/ROW.
  • Experience with variation procedures.


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