Global Regulatory Affairs Project Lead
2 days ago
About the Role
We are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.
Key Responsibilities
- Act as EU/ROW regulatory lead and EMA contact person for assigned project(s)
- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple clinical trial submission activities
- Evaluate competitive landscape and various regulatory mechanisms to optimize product development and expedite the path to market in EU/ROW
- Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, PRIME etc.
Requirements
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field
- Minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in proactively planning and executing complex clinical submission strategies
- Solid understanding of drug development and EU regulatory mechanisms
- Prior experience leading health authority meetings with the EMA or other health authorities, as well as experience with PIPs
- Strong project management skills
About You
- You have a passion for regulatory affairs and a genuine interest in our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do and are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
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