Global Regulatory Affairs Project Lead
1 month ago
At Genmab, we're committed to developing innovative antibody therapies that change the lives of patients and the future of cancer treatment. As a Global Regulatory Affairs Project Lead, you will play a key role in shaping our regulatory strategy for EU/ROW.
About the Role:
- You will represent RA in Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submissions in EU/ROW.
- You will lead the preparation of strategic regulatory documents and plan EMA or national Scientific Advice procedures as relevant.
- You will evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
- You will maintain an updated knowledge of regulatory topics and regulations, and participate in maintaining and preparing regulatory processes and ways of working.
Requirements:
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field. A Master's degree is preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in the development phase.
- Experience in proactively planning and executing complex clinical submission strategies.
- A good understanding of drug development and EU regulatory procedures. Experience within oncology is a plus.
About You:
- You are passionate about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best, and take pride in enabling the best work of others on the team.
We offer a competitive salary of approximately $140,000 per year, depending on experience. We also provide a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off. Additionally, we offer opportunities for professional growth and development, as well as a dynamic and inclusive work environment. Our office is located in Copenhagen, Denmark, and we leverage agile working environments to promote work-life balance.
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