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Regulatory Specialist II

Regulatory Specialist II - 39149 University Staff Description

University of Colorado Denver (Anschutz)University of Colorado Denver (Anschutz) has an opening for a Regulatory SpecialistRegulatory Specialist

Job Description:

Provide regulatory support and expertise throughout the lifecycle of projects that fall under the IND/IDE Office's oversight, primarily in the area of single patient compassionate use requests. Responsible for submission of single patient Compassionate Use Requests to various branches of FDA, and to internal entities per institutional policies. Support the Senior Regulatory Specialist as needed by ensuring all required documentation and sections/modules for submissions to FDA are complete and formatted per FDA requirements and by identifying missing or incomplete documentation and tracking and managing requests for outstanding documentation. Meet regularly with the PI and study team to review content and progress of application packages to various branches of FDA. Manage the submission of expedited and routine reports to FDA. Maintain version control for documentation throughout the IND/IDE's life cycle. Identify and elevate barriers delaying any FDA submissions and assists with identifying solutions. Participate in process improvement initiatives. Assist in developing and providing Standard Operating Procedures, educational resources and training for IND/IDE Office team members and investigators and their research teams. Work directly with the Office's Medical Directors, Principal Investigators (PIs) and collaborates with institutional partners including the Clinical Research Administrative Office, the IRB, and clinical teams. Position is 100% remote, reporting to University of Colorado Denver - Anschutz campus in Aurora, CO.

Job Requirements:

Requires a Must have experience in each of the following skills: Federal regulations and process for submitting INDs and IDEs to the FDA; Clinical trial regulatory work including submissions to institutional regulatory entities and external entities; Critically assessing a program solicitation; Project management; Maintaining and tracking regulatory data; Electronic Trial Master File systems and processes; Quality checks on published regulatory documentation; Content Verification processes; and SOP and work instruction development.

Salary: at least $66,664.00 per year.

93663835.v1-IMMIGRATION

Job Category
: Research Services Primary Location
: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21976 - ADM AVC Clinical Res Operation Schedule
: Full-time Posting Date
: Feb 26, 2026 Unposting Date
: Ongoing Position Number: 00809781

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=39149&lang=en

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