Manager, Regulatory Affairs Project Management

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

Role: Manager, Regulatory Project Management at RayzeBio, overseeing planning, execution, and coordination of regulatory submissions across clinical and nonclinical oncology programs.

Responsibilities

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

Requirements

• Bachelor's degree in a scientific field, minimum of 5 years in regulatory affairs or related roles, experience with global regulatory submissions, preferably NDA filings, and oncology development experience.

Skills

• strong cross-functional collaboration, project management proficiency (MS Project, Gantt charts), knowledge of global regulations, and effective communication.

High-value

• oncology therapeutics, radiopharmaceuticals, clinical development phases, GxP compliance, and cross-organizational stakeholder interaction.

Work setup

• Indianapolis-based; no explicit travel details provided.