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Regulatory Manager EU/ROW

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Job

As Associate Director, EU/ROW Regulatory Lead, you will play a critical role in Genmab's Global Regulatory Affairs organization. Your primary responsibility will be to lead the development and execution of EU/ROW regulatory strategies for assigned projects.

Your Key Objectives
  1. Develop and implement EU/ROW regulatory strategies to ensure compliance with regulations and guidance.
  2. Lead preparation of strategic regulatory documents, including Briefing Packages and ODDs.
  3. Collaborate with cross-functional teams to evaluate regulatory risks and recommend mitigation strategies.
What We Offer
  • Opportunity to work on high-profile projects with a global impact.
  • Collaborative team environment with experienced professionals.
  • Ongoing training and development opportunities to enhance your skills and expertise.