Regulatory Affairs Director
2 weeks ago
About the Role
The Senior Director of Regulatory Affairs will join our Global Regulatory Affairs team, leading the EU/ROW regulatory strategy for assigned programs and managing a group of Regulatory Strategists.
Key Responsibilities
- Develop and implement global regulatory strategies for assigned projects, integrating regional strategies and aligning with global development goals.
- Lead planning and implementation of regional regulatory procedures, including clinical trial applications and marketing authorizations.
- Represent Regulatory Affairs across Genmab committees and interact with health authorities, evaluating and communicating regulatory risks and challenges.
- Oversee CRO quality, accountabilities, and deliverables related to Regulatory activities, assessing EU and MHRA regulatory guidelines and regulations.
- Ensure compliance with internal and external requirements, participating in regulatory SOP development and providing input into streamlining internal RA processes.
Requirements
- Bachelor's degree or equivalent in a scientific discipline or health-related field, with a minimum of 10 years of experience in Regulatory Affairs.
- Significant experience in planning and implementing complex clinical submission strategies, leading a team of regulatory strategist professionals, and expertise in drug development and EU regulatory mechanisms.
- Strong project management skills, attention to detail, and ability to problem-solve, with a proven track record of driving projects to successful outcomes.
- Robust cross-functional collaboration skills, with experience working in a global environment and building/maintaining internal and external collaborative relationships.
About Genmab
- Genmab is a biotechnology company focused on developing innovative cancer treatments, leveraging an agile working environment and state-of-the-art laboratories to drive innovation.
- We thrive on connecting with each other to drive progress, and our offices are designed as open, community-based spaces that foster collaboration and connection.
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