Global Regulatory Affairs Director
1 week ago
The Global Regulatory Affairs Director will assume responsibility for the EU/ROW regulatory strategy for an assigned program and manage a group of Regulatory Strategists with EU/ROW responsibilities.
Key Responsibilities- Develop global regulatory strategies for assigned projects through integration of regional regulatory strategies and in line with global development and commercial goals.
- Lead or be responsible for the planning and implementation of regional regulatory procedures, such as clinical trial applications, marketing applications, label extensions, and CMC changes.
- Represent Regulatory Affairs across Genmab committees as indicated.
Requirements
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field. PhD or MD degree is preferred.
- Minimum of 10 years of experience in Regulatory Affairs, across all development phases.
- Significant experience in planning and implementing complex clinical submission strategies.
- You have a strong passion for our purpose and genuinely care about our mission to transform lives through innovative cancer treatment.
- You bring rigor and excellence to all that you do, believing in our rooted-in-science approach to problem-solving.
- You are a generous collaborator who can work in teams with diverse backgrounds.
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleGenmab is seeking a highly skilled Director/Associate Director to join its Regulatory Affairs CMC team. The successful candidate will be responsible for developing and executing global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.The ideal candidate will have a strong understanding of...
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