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Senior Director, Regulatory Affairs Strategy-EU/RoW
2 maanden geleden
We are seeking a highly experienced Senior Director to lead our Regulatory Affairs team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.
Key Responsibilities- Develop and implement global regulatory strategies for assigned projects, integrating regional regulatory strategies with global development and commercial goals.
- Lead or be responsible for planning and implementing regional regulatory procedures, including clinical trial applications, marketing applications, label extensions, CMC changes, and PIPs.
- Represent Regulatory Affairs across Genmab committees as indicated, and interact with health authorities and lead/participate in health authority meetings.
- Evaluate regulatory mechanisms that allow optimization of product development, such as orphan drug designation, PRIME designation, compassionate use, and pediatric plans.
- Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs, and participate in regulatory SOP development.
- A minimum of 10 years of experience in Regulatory Affairs, across all development phases.
- Significant experience in proactively planning and implementing highly complex clinical submission strategies.
- Experience in leading a team of regulatory strategist professionals, and expertise in drug development and EU regulatory mechanisms to expedite development.
- Strong project management skills, and ability to work independently with an ability to drive projects to successful outcomes.
- Robust cross-functional collaboration skills, and ability to build and maintain internal and external collaborative relationships to achieve shared goals.
Genmab is a biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. We are committed to rigor and excellence in all that we do, and are seeking a talented individual who shares our passion for our purpose and mission.
