IND/IDE Regulatory Strategy Leader

University of Colorado; South Dakota; Hybrid; USD 120,000 - 170,000; Full time

Job summary

University of Colorado Anschutz seeks an experienced Regulatory Strategist Program Manager to lead regulatory strategy and manage IND/IDE submissions. You will collaborate with OVCR, Cancer Center, Gates Institute, and CHCO to support CU-held INDs and investigator-held INDs, ensuring alignment with FDA requirements.

Responsibilities include developing strategy, coordinating external consultants, and mentoring faculty on regulatory needs; the role emphasizes FDA regulations (21 CFR Parts 312,

Qualifications

• Expertise in FDA regulations (21 CFR Parts 312, 812).
• Experience developing regulatory strategy for IND/IDE and ARPA-H projects.
• Ability to collaborate with internal and external stakeholders across multiple institutes.

Responsibilities

• Regulatory Strategy and Project Management – 50% of time.
• External Consultant and Subcontractor Management – 25% of time.
• Regulatory Specialist Responsibilities – 25% of time; primary FDA submissions contact; maintain TMF and documentation.

Skills

Regulatory strategy

Project management

FDA submissions

Stakeholder engagement

Job description

University of Colorado Anschutz seeks an experienced Regulatory Strategist Program Manager to lead regulatory strategy and manage IND/IDE submissions. You will collaborate with OVCR, Cancer Center, Gates Institute, and CHCO to support CU-held INDs and investigator-held INDs, ensuring alignment with FDA requirements.

Responsibilities include developing strategy, coordinating external consultants, and mentoring faculty on regulatory needs; the role emphasizes FDA regulations (21 CFR Parts 312,