Regulatory Project Lead, Global Submissions

Regulatory Jobs; Indianapolis (IN); On-site; USD 135,000 - 163,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, is seeking a Manager, Regulatory Project Management to lead regulatory submissions and cross‑functional programs across clinical and nonclinical pipelines. You will shape timelines, drive communications, and ensure on‑time, compliant filings in alignment with program goals.

The role reports to the Head of Regulatory Project Management and requires 5+ years in regulatory affairs/project management, with oncology experience and a strong

Qualifications

• Bachelor’s degree 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.

Responsibilities

• Plan, coordinate, and execute regulatory submissions and activities (INDs, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
• Develop, maintain, and manage detailed regulatory project timelines and schedules.
• Monitor progress, identify risks or issues, and escalated mitigation strategies.
• Serve as the primary regulatory project management contact for submissions.
• Communicate project status, risks, and progress to stakeholders and leadership.
• Collaborate with Program Management to align regulatory timelines with integrated programs.
• Facilitate cross-functional meetings and define roles and deliverables.
• Prepare submission trackers and project dashboards; document milestones and decisions.
• Provide regular status updates to Regulatory Affairs leadership and teams.

Skills

Cross-functional comms

Regulatory planning

IND/CTA/NDA

Project management

Radiopharma exp

Oncology regs

Gantt/MS Project

MS Office

Regulatory submissions

Team leadership

Education

Bachelor’s degree

Life sciences

Tools

MS Project

Smartsheet

MS Office

Job description

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, is seeking a Manager, Regulatory Project Management to lead regulatory submissions and cross‑functional programs across clinical and nonclinical pipelines. You will shape timelines, drive communications, and ensure on‑time, compliant filings in alignment with program goals.

The role reports to the Head of Regulatory Project Management and requires 5+ years in regulatory affairs/project management, with oncology experience and a strong