Regulatory Projects Lead – Oncology Biotech

Bristol Myers Squibb; Indianapolis (IN); In loco; USD 135.000 - 163.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health Coverage

Wellbeing Programs

401(k) Plan

Paid Time Off

Descrizione del lavoro

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Manager, Regulatory Affairs Project Management in Indianapolis, IN. The role focuses on planning and coordinating regulatory submissions for oncology programs, ensuring timelines align with program goals and leadership expectations.

You will drive cross-functional collaboration, manage trackers and dashboards, and report milestones to Regulatory Affairs leadership while supporting global submissions and project execution.

Competenze

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

Mansioni

• Lead planning, coordination, and execution of regulatory submissions and activities (INDs, CTAs, NDAs, etc.).
• Develop and manage detailed regulatory timelines and schedules.
• Provide regular status updates to Regulatory Affairs leadership and cross-functional teams.

Conoscenze

Regulatory submissions

Cross-functional comms

MS Project

Smartsheet

MS Office

Radiopharmaceutical experience

AI in teams

Formazione

Bachelor's degree or higher in a scientific field

Strumenti

MS Project

Smartsheet

MS Office

Descrizione del lavoro

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Manager, Regulatory Affairs Project Management in Indianapolis, IN. The role focuses on planning and coordinating regulatory submissions for oncology programs, ensuring timelines align with program goals and leadership expectations.

You will drive cross-functional collaboration, manage trackers and dashboards, and report milestones to Regulatory Affairs leadership while supporting global submissions and project execution.