Global Regulatory Expertise Leader
4 days ago
Genmab is an international biotechnology company dedicated to improving patient lives through innovative antibody therapeutics. We're seeking an experienced professional to fill the position of (Associate) Director, Global Regulatory Affairs Project Lead.
About the Role
- This role requires collaboration with the Global Regulatory Team to develop and execute EU/ROW regulatory strategies for our compounds
- You will represent RA in Clinical Trial Teams and ensure regulatory oversight of clinical trial submission activities
- Your responsibilities will also include evaluating competitive landscapes and regulatory mechanisms to optimize product development and expedite market entry in EU/ROW
Key Responsibilities
- Developing and executing EU/ROW regulatory strategies for assigned projects
- Representing RA in Clinical Trial Teams and ensuring regulatory oversight of clinical trial submission activities
- Collaborating with the Global Regulatory Team to identify and mitigate regulatory risks
Requirements
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred
- Minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in planning and executing complex clinical submission strategies
- A solid understanding of drug development and EU regulatory mechanisms
- Prior experience leading health authority meetings with the EMA or other health authorities
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