Global Regulatory Lead
Job Summary
Leading high-stakes oncology programs, the remote Global Regulatory Lead will manage regulatory strategy from concept to Health Authority approval, direct cross-functional regulatory sub-teams, and drive the submission process for cutting-edge therapies on a contract basis.
Key responsibilities
- Represent Regulatory Affairs in Global Project Team(s) and lead the regulatory sub-team (GRST) for assigned projects
- Drive the regulatory submission process and ensure high-quality preparation of all regulatory documentation
- Develop optimal regulatory strategies aligned with the development plan and manage major regulatory agency interactions
Required qualifications
- Advanced degree with at least 6 years of relevant experience
- A minimum of 3 years of recent oncology experience
- Proven strategist with successful interactions with FDA or EMA
- Demonstrated strong matrix leadership skills
Complete Job Description
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