Regulatory Submissions Project Lead – Oncology

Bristol-Myers Squibb Co; Indianapolis (IN); Híbrido; USD 135.000 - 163.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Coverage

401(k) plan

Paid Time Off

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Project management

Cross-functional collaboration

Communication

Decision making

Educación

Bachelor’s degree or higher in a scientific discipline

Herramientas

MS Project

Smartsheet

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

Descripción del empleo

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.