Regulatory Strategy Lead, IND/IDE & FDA Submissions

A prominent research institution in Colorado is seeking a Regulatory Strategist Manager to develop and execute regulatory strategies for IND/IDE studies. This hybrid role involves working with investigators on regulatory issues, managing external consultants, and ensuring compliance with FDA submissions. The ideal candidate will possess strong knowledge of FDA regulations, project management skills, and effective communication abilities, along with a minimum of 4–6 years in regulatory support and strategy. #J-18808-Ljbffr