Regulatory Strategist Program Manager

The Regulatory Strategist Program Manager develops and implements regulatory strategies for IND/IDE studies at CU Anschutz, supporting both institution-held and investigator-held trials. This high-visibility role involves collaborating with internal leaders, external consultants, and funding agencies to ensure compliance with FDA regulations and facilitate the operational conduct of clinical trials. The position requires expertise in early-phase drug development and managing complex regulatory submissions for multi-stakeholder projects.