Manager, Regulatory Affairs Project Management

Role: Manager of Regulatory Project Management supporting biopharma clinical and nonclinical programs, primarily in oncology, with a focus on radiopharmaceutical therapies. Responsibilities include leading strategic planning, coordination, and execution of regulatory submissions such as INDs, CTAs, NDAs, and amendments; managing cross-functional timelines and deliverables; and serving as a key point of contact for regulatory activities. The role involves proactive risk management, communication with internal stakeholders, and maintaining submission documentation and dashboards. Requirements: Bachelor’s degree in a scientific discipline; minimum of 5 years' experience in regulatory affairs, project management, or related life sciences; experience supporting or leading global regulatory submissions, preferably in oncology and radiopharmaceuticals; and proficiency with regulatory standards and project management tools. Preferred qualifications include NDA filing experience and familiarity with all phases of clinical development within oncology. The position reports to the Head of Regulatory Project Management, with responsibilities spanning global regulatory processes and collaboration across clinical, nonclinical, and regulatory teams. The work environment is office-based in Indianapolis, with a focus on timely, high-quality regulatory submissions to support innovative cancer therapies.