Leadership Role in Global Regulatory Affairs
3 days ago
About the Position
Genmab is seeking an experienced Senior Director to lead our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and executing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.
Key Responsibilities:
- Develop and implement global regulatory strategies for assigned projects
- Lead and mentor a team of dedicated Regulatory Strategists with EU/Rest of World (ROW) responsibilities
- Interface directly with health authorities, such as the European Medicines Agency (EMA)
- Oversee regulatory Contract Research Organizations (CROs) for territories outside Japan and the US
- Evaluate and communicate regulatory risks and challenges to senior management
- Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs
Requirements:
- Bachelor's degree or equivalent in a scientific discipline or health-related field; PhD or MD degree preferred
- Minimum 10 years of experience in Regulatory Affairs, across all development phases
- Significant experience in proactively planning and implementing complex clinical submission strategies
- Experience leading a team of regulatory strategist professionals
- Expertise in drug development and EU regulatory mechanisms to expedite development
Location: Copenhagen, Denmark
Estimated Salary: $140,000 - $170,000 per year, depending on experience and qualifications
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