Senior Regulatory Affairs Specialist
2 weeks ago
Genmab seeks a highly skilled and experienced Senior Regulatory Affairs Specialist to join its Global Regulatory Affairs organization. As a key member of the team, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects. Your expertise in EU regulatory mechanisms and prior experience working with the EMA will be invaluable in ensuring the optimal EU/ROW regulatory strategy for our compounds.
Key Responsibilities
- Develop and execute EU/ROW regulatory strategies for assigned projects
- Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities
- Evaluate competitive landscape and various regulatory mechanisms to optimize product development and present options and recommendations to expedite the path to market in EU/ROW
- Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, and PRIME
- Plan, prepare, and lead EU and national Scientific Advice procedures as relevant
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
- Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on Genmab products
- Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working
Requirements
- Bachelor's degree or equivalent in scientific discipline or health-related field; Master's degree preferred
- Minimum 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in proactively planning and executing highly complex clinical submission strategies
- Solid understanding of drug development and EU regulatory mechanisms to expedite development; experience within oncology a plus
- Prior experience leading health authority meetings with the EMA or other health authorities, as well as experience with PIPs
- Strong project management skills
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