Manager, Regulatory Affairs Project Management Indianapolis - RayzeBio - IN R1605576

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio:

The Manager, Regulatory Project Management is responsible for planning, executing, and driving regulatory submissions and regulatory project activities across clinical and nonclinical programs. This role manages cross-functional timelines, deliverables, and communication to ensure high-quality, on-time regulatory submissions in alignment with program and organizational objectives. The position reports to the Head of Regulatory Project Management.

• Project Planning and Execution of Regulatory Submissions
  • Lead the planning, coordination, and execution of regulatory submissions and activities (e.g., INDs and amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
  • Develop, maintain, and proactively manage detailed regulatory project timelines and schedules.
  • Monitor project progress, identify risks or issues, and elevate proactively with proposed mitigation strategies.
• Cross-functional Communication and Coordination
  • Serve as the primary regulatory project management point of contact for assigned submissions.
  • Communicate project status, risks, and progress to internal stakeholders and leadership.
  • Collaborate closely with Program Management to ensure regulatory timelines align with integrated program timelines and expectations.
  • Facilitate cross-functional meetings and ensure clarity of roles, responsibilities, and deliverables.
• Documentation and Reporting
  • Prepare and maintain regulatory submission trackers and project dashboards.
  • Document key milestones, decisions, and action items.
  • Provide regular, clear status updates to Regulatory Affairs leadership and cross-functional teams.

• Bachelor’s degree or higher in a scientific or related discipline.
• Minimum of 5 years of experience in regulatory affairs, project management, life sciences, or healthcare.
• Hands-on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.
• Experience supporting oncology development programs.

• Strong interpersonal skills with the ability to build and maintain effective cross-functional relationships.
• Flexibility and adaptability in a fast- paced, dynamic development environment.
• Strong decision-making skills and ability to navigate ambiguous situations
• Demonstrated record of strong communication and teamwork in a cross-functional environment.
• Highly organized with the ability to manage multiple complex projects simultaneously.
• Ability to think through projects of varying complexity and execute independently from initiation through completion.
• Strong written and verbal communication skills.
• Working knowledge of relevant global regulations, guidances, and regulatory standards.
• Professional, proactive, and confident approach with high ethical standards.
• Experience with all phases of clinical development
• Demonstrable proficiency in project timeline and Gantt chart software (eg, MS Project, Smartsheet), MS Office (e.g., Outlook, Word, PowerPoint, Excel, and Teams)
• Radiopharmaceutical experience
• Applies AI to improve team execution and decision-making