Director, EU/ROW Regulatory Affairs
2 days ago
About the Team
Our Global Regulatory Affairs team is responsible for ensuring that Genmab's programs meet regulatory requirements and are developed and implemented in accordance with EU and international regulations. We work closely with cross-functional teams to ensure that our programs are developed and implemented in a way that meets regulatory requirements and enables an integrated global clinical development and commercial strategy.
The ideal candidate will have significant experience in proactively planning and implementing complex clinical submission strategies, as well as leading teams of regulatory professionals. A strong understanding of drug development and EU regulatory mechanisms is essential, with expertise in expedited development pathways such as orphan drug designation and PRIME designation.
You will be responsible for developing and implementing global regulatory strategies for assigned projects, leading or being responsible for planning and implementation of regional regulatory procedures, and representing Regulatory Affairs across Genmab committees as indicated.
Responsibilities
- Develop and implement global regulatory strategies for assigned projects
- Lead or be responsible for planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions)
- Represent Regulatory Affairs across Genmab committees as indicated
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