Regulatory Affairs PM Lead — Oncology Submissions

Bristol-Myers Squibb; Indianapolis, Northern (IN, KY); Hybrid; 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, Indianapolis, seeks a Manager, Regulatory Affairs Project Management to plan and drive regulatory submissions for oncology programs. You will lead cross-functional teams, manage timelines, and ensure on-time submissions.

This role reports to the Head of Regulatory Project Management and supports INDs, CTAs, NDAs, and related activities. Ideal candidates have 5+ years in regulatory affairs or project management within life sciences,

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 5 years' experience in regulatory affairs or project management in life sciences/healthcare.
• Hands-on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.

Responsibilities

• Lead planning, coordination, and execution of regulatory submissions and activities (INDs, CTAs, NDAs, etc.).
• Develop and manage detailed regulatory project timelines and schedules; monitor progress and risks.
• Serve as the primary regulatory PM contact for submissions and collaborate cross-functionally to align timelines.

Skills

Regulatory PM

Cross-functional

Communication

MS Project

Smartsheet

GxP knowledge

Oncology

Education

Bachelor's degree in science

Tools

MS Project

Smartsheet

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, Indianapolis, seeks a Manager, Regulatory Affairs Project Management to plan and drive regulatory submissions for oncology programs. You will lead cross-functional teams, manage timelines, and ensure on-time submissions.

This role reports to the Head of Regulatory Project Management and supports INDs, CTAs, NDAs, and related activities. Ideal candidates have 5+ years in regulatory affairs or project management within life sciences,