Regulatory Submissions Project Lead (Oncology)

Biopharma Careers; Indianapolis (IN); On-site; USD 135,000 - 163,000; Full time

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, is developing transformative radiopharmaceutical therapies to help cancer patients. The Manager, Regulatory Project Management leads regulatory submissions and cross‑functional program activities, ensuring on‑time, high‑quality filings across clinical and nonclinical programs.

In this role you’ll craft timelines, coordinate with stakeholders, manage risks, and oversee trackers and dashboards.

Qualifications

• Bachelor’s degree or higher in a scientific or related discipline.

Responsibilities

• Lead regulatory submissions and activities (e.g., INDs, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
• Develop and manage detailed regulatory project timelines and schedules.
• Monitor progress, identify risks, and propose mitigation; communicate status to stakeholders.
• Serve as regulatory project management point of contact for submissions and cross‑functional teams.
• Prepare regulatory submission trackers and dashboards; document milestones and decisions.

Skills

Cross-functional collaboration

Regulatory project management

Regulatory strategy

Program coordination

Communication

MS Project

Smartsheet

Radiopharmaceuticals

AI for execution

Education

Bachelor's degree or higher in science

Tools

MS Project

Smartsheet

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, is developing transformative radiopharmaceutical therapies to help cancer patients. The Manager, Regulatory Project Management leads regulatory submissions and cross‑functional program activities, ensuring on‑time, high‑quality filings across clinical and nonclinical programs.

In this role you’ll craft timelines, coordinate with stakeholders, manage risks, and oversee trackers and dashboards.