Regulatory Project Lead – Biotech Radiopharma

Bristol-Myers Squibb Co; 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, seeks a Manager of Regulatory Project Management to lead global regulatory submissions across oncology programs. You will manage cross-functional timelines, deliverables, and communication to ensure timely, high-quality submissions.

Reports to Head of Regulatory Project Management. The role requires 5+ years in regulatory affairs or healthcare and a strong background in major submissions (NDA/IND) with radiopharmaceutical exposure.

Qualifications

• Bachelor’s degree or higher in a scientific field.
• Minimum 5 years in regulatory affairs, project management, life sciences, or 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, MAAs, etc.).
• Develop and maintain detailed regulatory project timelines and schedules.
• Provide regular status updates to Regulatory Affairs leadership and cross-functional teams.

Skills

Regulatory PM

Cross-functional

MS Project

Smartsheet

NDA/IND

Oncology

Radiopharma

AI in PM

Team leadership

Regulatory submissions

Education

Bachelor’s degree or higher in a scientific discipline

Tools

MS Project

Smartsheet

Excel

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Manager of Regulatory Project Management to lead global regulatory submissions across oncology programs. You will manage cross-functional timelines, deliverables, and communication to ensure timely, high-quality submissions.

Reports to Head of Regulatory Project Management. The role requires 5+ years in regulatory affairs or healthcare and a strong background in major submissions (NDA/IND) with radiopharmaceutical exposure.