EU Regulatory Specialist
4 days ago
As a Regulatory Affairs Director EU/ROW Lead at Genmab A/S, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects.
About the RoleThis is a key member position within the Global Regulatory Affairs organization at Genmab A/S.
- Key Accountabilities:
- Act as EU/ROW Regulatory Lead for assigned projects.
- Develop and execute EU/ROW regulatory strategies.
- Ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Lead the preparation of strategic regulatory documents.
What We Are Looking For:
- Minimum of 8 years of experience in Regulatory Affairs.
- Proven track record of developing and executing regulatory strategies.
- Excellent project management skills.
- Prior experience leading health authority meetings.
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