Remote Regulatory Project Manager - Oncology Submissions

Bristol Myers Squibb; United States; À distance; USD 135 000 - 163 000; Plein temps

Avantages offerts par ce poste

Health Coverage

Wellbeing Support

Financial Well-being

Paid Time Off

Résumé du poste

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager, Regulatory Project Management to plan and drive regulatory submissions across clinical and nonclinical programs. You will manage cross-functional timelines, deliverables, and communication to ensure on-time submissions in alignment with program objectives.

The role reports to the Head of Regulatory Project Management and requires strong collaboration, strategic thinking, and experience with major global

Qualifications

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

Responsabilités

• Plan, coordinate, and execute regulatory submissions and activities (e.g., INDs, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
• Develop and manage detailed regulatory project timelines and schedules.
• Maintain regulatory submission trackers and dashboards; communicate status to leadership.

Connaissances

Regulatory project management

Cross-functional leadership

Regulatory submissions

GxP knowledge

Project timelines

Communication skills

Oncology regulatory experience

AI in project execution

Formation

Bachelor’s degree or higher in a scientific field

Outils

MS Project

Smartsheet

MS Office

Regulatory databases

Description du poste

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager, Regulatory Project Management to plan and drive regulatory submissions across clinical and nonclinical programs. You will manage cross-functional timelines, deliverables, and communication to ensure on-time submissions in alignment with program objectives.

The role reports to the Head of Regulatory Project Management and requires strong collaboration, strategic thinking, and experience with major global