Regulatory Affairs Strategy Leader
6 days ago
We are seeking a highly experienced Regulatory Affairs Strategy Leader to join our Global Regulatory Affairs organization. This role will lead the development and implementation of regulatory strategies for assigned programs in the EU/ROW region.
About YouYou will be responsible for managing a team of regulatory strategists and working closely with cross-functional teams to ensure alignment with global development and commercial goals.
Key Responsibilities- Develop and implement regulatory strategies for assigned programs
- Lead and manage a team of regulatory strategists
- Collaborate with cross-functional teams to ensure alignment with global development and commercial goals
- Represent Regulatory Affairs across Genmab committees as indicated
- Evaluate and communicate regulatory risks and challenges to senior management
- Oversee CRO quality, accountabilities and deliverables related to Regulatory activities
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. PhD or MD degree will be preferred.
- Minimum of 10 years of experience in Regulatory Affairs, across all development phases
- Significant experience in proactively planning and implementing complex clinical submission strategies
- Experience in leading a team of regulatory strategist professionals
- Expertise in drug development and EU regulatory mechanisms to expedite development
- Experience within oncology is preferred
As a Regulatory Affairs Strategy Leader at Genmab, you can expect a competitive salary of $180,000 - $220,000 per annum, depending on your experience and qualifications. Our company offers an agile working environment, collaborative office spaces, and opportunities for professional growth and development.
We thrive on connecting with each other to innovate and drive success. If you are a motivated and results-driven individual who enjoys a fast-paced work environment, we encourage you to apply for this exciting opportunity.
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