Regulatory Project Lead – Oncology Submissions

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

RayzeBio seeks a Manager, Regulatory Project Management to oversee planning, execution, and coordination of regulatory submissions across clinical and nonclinical oncology programs. Based in Indianapolis, you will lead IND/NDAs/CTAs, build timelines, and ensure timely, high-quality deliverables in collaboration with cross-functional teams.

Ideal candidates have a scientific degree and 5+ years in regulatory affairs, with experience in global submissions and oncology development.

Qualifications

• Bachelor's degree in a scientific field.
• 5+ years in regulatory affairs or related roles.
• Experience with global regulatory submissions, preferably NDA filings.
• Oncology development experience preferred.

Responsibilities

• Lead regulatory submission processes (INDs, NDAs, CTAs), develop project timelines, manage cross-functional communication, and ensure timely, high-quality deliverables.

Skills

Cross-functional collaboration

Project management

Global regulations knowledge

Communication

Education

Bachelor's degree in a scientific field

Tools

MS Project

Gantt charts

Job description

RayzeBio seeks a Manager, Regulatory Project Management to oversee planning, execution, and coordination of regulatory submissions across clinical and nonclinical oncology programs. Based in Indianapolis, you will lead IND/NDAs/CTAs, build timelines, and ensure timely, high-quality deliverables in collaboration with cross-functional teams.

Ideal candidates have a scientific degree and 5+ years in regulatory affairs, with experience in global submissions and oncology development.