Regulatory Affairs Expert
4 weeks ago
Genmab is seeking a highly skilled Regulatory Affairs professional to lead our EU/ROW Regulatory Strategy team. As a key member of our Global Regulatory Affairs organization, you will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.
Key Responsibilities:
- Represent RA in Clinical Trial Teams and ensure regulatory oversight and progress of multiple, complex clinical trial submission activities.
- Develop and execute EU/ROW regulatory strategies for assigned projects.
- Lead the preparation of strategic regulatory documents, such as Briefing Packages and ODDs.
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
- Monitor and assess regulatory guidelines and regulations, and their impact on Genmab products.
Requirements:
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
- Experience in proactively planning and executing complex clinical submission strategies.
- Prior experience leading health authority meetings with the EMA or other health authorities.
- Strong project management skills and ability to work independently.
- Robust cross-functional teamwork skills and ability to build and maintain internal and external collaborative relationships.
About Genmab
Genmab is a biotechnology company dedicated to transforming the lives of patients with cancer. We are committed to innovation and excellence in our products and services.
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