Manager, Regulatory Affairs Strategy - Oncology

Role: Manager, Regulatory Affairs Strategy Oncology at Regeneron, supporting global regulatory submissions and agency communications for novel therapeutics in oncology. Responsibilities: coordinate submission of INDs/CTAs, amendments, orphan drug applications, and reports; assist in agency meeting preparations; track and respond to regulatory agency queries; represent study-level regulatory activities; collaborate cross-functionally on product development. Requirements: MD, PhD, or PharmD with 2+ years of regulatory experience, including filings, document development, and external partner engagement; strong knowledge of US FDA and international regulations; experience managing CRO interactions for clinical trial activations, particularly outside US/EU preferred; high attention to detail and excellent communication skills. High-Value: oncology focus, regulatory submissions for clinical/nonclinical development, global agency interactions, experience with US FDA and international guidelines, cross-functional collaboration, on-site in Tarrytown, NY or Warren, NJ, with some travel.