Manager, Regulatory Affairs Strategy - Oncology

Role: Regulatory Affairs Manager within Oncology, supporting global regulatory submissions and agency interactions for novel therapeutics. Responsibilities: coordinate preparation, submission, and maintenance of INDs/CTAs, orphan drug applications, and reports; assist in agency meetings and briefing documents; track and respond to regulatory queries; represent study-level activities in cross-functional teams. Requirements: MD, PhD, or PharmD with 2+ years regulatory experience, experience with filings, developing regulatory documents, and engaging with external partners; strong knowledge of US FDA and international regulations; preferred experience managing ex-US/ex-EU CTAs and CRO interactions. HighValue: oncology, regulatory submissions, global approvals, agency coordination, cross-functional collaboration. WorkSetup: onsite in Tarrytown, NY or Warren, NJ, 4 days/week.