Global Regulatory Lead
$178,500–$257,833 year
On-site · Cambridge, Massachusetts, United States or Morristown, New Jersey, United States
Job Summary
Global Regulatory Lead responsible for developing and executing global regulatory strategies for oncology products, leading the Global Regulatory Project Strategy, submission strategy, and lifecycle labeling; supervising the Global Regulatory Team and fostering a high-performance culture; coordinating Health Authority interactions and regulatory accelerations; driving strategic regulatory leadership across global programs (including sBLA/sNDA/MAA/INDs) and cross-functional governance, with extensive experience in oncology and 8–10 years in Regulatory Affairs; BS/BA required with advanced degree preferred, and readiness to operate in a US-based, on-site environment in Morristown, NJ or Cambridge, MA.
Required Qualifications
- BS/BA degree in a relevant scientific discipline required
- Advanced degree preferred (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
- At least 8-10 years of pharmaceutical/biotechnology experience with at least 6 years in Regulatory Affairs
- Experience leading Health Authority interactions in major markets
- Experience preparing regulatory submissions (sBLA, sNDA, or MAA, INDs) and negotiating with Health Authorities
- Experience leading filings/registrations and obtaining regulatory action in major markets
- Project leadership and team-development experience
- Oncology experience preferred
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