**Regulatory Affairs Program Manager**

**Description**

**University of Colorado Anschutz Medical Campus** **Department: Ophthalmology**

**Job Title: Regulatory Affairs Program Manager**

**Position #00849808 - Requisition #40277**

**Job Summary:**

Key Responsibilities:

+ Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
+ Coordinate regulatory documentation for industry-sponsored clinical trials and investigator-initiated studies for all clinical research in Ophthalmology
+ Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
+ Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
+ Track and maintain investigator qualifications, including CVs, medical li...