Manager, Regulatory Affairs Project Management

Role: Manager, Regulatory Project Management at RayzeBio, overseeing planning, execution, and coordination of regulatory submissions across clinical and nonclinical oncology programs. Responsibilities: lead regulatory submission processes (e.g., INDs, NDAs, CTAs), develop project timelines, manage cross-functional communication, and ensure timely, high-quality regulatory deliverables. Requirements: Bachelor's degree in a scientific field, minimum of 5 years in regulatory affairs or related roles, experience with global regulatory submissions, preferably NDA filings, and oncology development experience. Skills: strong cross-functional collaboration, project management proficiency (MS Project, Gantt charts), knowledge of global regulations, and effective communication. High-value: oncology therapeutics, radiopharmaceuticals, clinical development phases, GxP compliance, and cross-organizational stakeholder interaction. Work setup: Indianapolis-based; no explicit travel details provided.