Regulatory Project Lead, Oncology & Radiopharma

Bms; Indianapolis (IN); Hybrid; USD 135,000 - 163,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and insurance

Paid time off

Job summary

RayzeBio, a Bristol Myers Squibb company, seeks a Manager, Regulatory Project Management to plan and execute regulatory submissions across clinical and nonclinical programs. You will manage cross-functional timelines, trackers, and communication to ensure high-quality, on-time submissions aligned with program goals.

The role requires at least 5 years in regulatory affairs or project management, experience with major global submissions, and oncology development exposure.

Qualifications

• Bachelor's degree or higher in a scientific field.
• 5+ years of regulatory affairs/project management experience.
• Hands-on experience with major global regulatory submissions, NDA preferred.
• Experience supporting oncology development programs.

Responsibilities

• Plan, coordinate, and execute regulatory submissions (INDs, CTAs, NDAs, MAAs, etc.).
• Develop and maintain detailed regulatory project timelines and schedules.
• Monitor progress, identify risks, and propose mitigation strategies.
• Communicate status to stakeholders and align with program timelines.
• Prepare submission trackers and dashboards and document milestones.

Skills

Cross-functional leadership

Project management

Regulatory knowledge

Oncology experience

Communication skills

Organizational skills

AI in team execution

Education

Bachelor’s degree or higher in a scientific discipline

NDA filing experience

Tools

MS Project

Smartsheet

MS Office

Regulatory software

Gantt charts

Job description

RayzeBio, a Bristol Myers Squibb company, seeks a Manager, Regulatory Project Management to plan and execute regulatory submissions across clinical and nonclinical programs. You will manage cross-functional timelines, trackers, and communication to ensure high-quality, on-time submissions aligned with program goals.

The role requires at least 5 years in regulatory affairs or project management, experience with major global submissions, and oncology development exposure.