Regulatory Submissions Project Lead – Oncology

Nutanix; Indianapolis, Northern (IN, KY); Hybrid; 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, seeks a Manager of Regulatory Project Management to drive regulatory submissions across clinical and nonclinical programs. You will coordinate timelines, risks, and deliverables while partnering with cross-functional teams to meet program objectives.

You will oversee INDs/NDAs/CTAs and maintain trackers, dashboards, and status updates for Regulatory Affairs leadership. This role emphasizes collaboration and strategic execution.

Qualifications

• Bachelor’s degree or higher in a scientific or related discipline.
• Minimum of 5 years of experience in regulatory affairs or healthcare.
• Hands-on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.
• Experience supporting oncology development programs.

Responsibilities

• Lead planning, coordination, and execution of regulatory submissions and activities (e.g., INDs, CTAs, NDAs, MAAs, IMPDs).
• Develop and manage detailed regulatory project timelines and schedules.
• Communicate project status, risks, and progress to stakeholders and leadership.
• Coordinate cross-functional meetings and ensure clarity of roles and deliverables.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Communication

Decision making

Education

Bachelor’s degree or higher in a scientific discipline

Tools

MS Project

Smartsheet

MS Office (Outlook, Word, PowerPoint, Excel, Teams)

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Manager of Regulatory Project Management to drive regulatory submissions across clinical and nonclinical programs. You will coordinate timelines, risks, and deliverables while partnering with cross-functional teams to meet program objectives.

You will oversee INDs/NDAs/CTAs and maintain trackers, dashboards, and status updates for Regulatory Affairs leadership. This role emphasizes collaboration and strategic execution.