Program Director of Regulatory Affairs

University of Colorado Anschutz Medical Campus

Department : Medicine - ClinImmune - The Center for Clinical Immunology

Job Title : Program Director of Regulatory Affairs

Position # : 00841145 - Requisition # : 38029

Job Summary

This position is responsible for assisting the Director of Regulatory Affairs with oversight of the ClinImmune Cell and Gene Therapy, Histocompatibility, Stem Cell Laboratories and Cord Blood Banks to maintain compliance with regulatory agencies and accrediting organizations, including FDA, CLIA, ASHI, FACT, AATB, AABB, state agencies, NMDP, UNOS, lRB, and CAP.

Key Responsibilities

• Regulatory & Clinical Laboratory Compliance – including submissions, and compliance with quality and federal guidelines and reporting.
• Quality Assurance and reporting for the Clinical Lab – working with the Histocompatibility, Cord Blood Banks and Cell and Gene Therapies Laboratory directors, supervisors, and managers to assure efficient reporting and safe, pure, and potent product and testing release.
• Cellular Therapy campus wide quality program – providing review of all quality management programs and interactions with UCH BMT staff, UCH Pharmacy P&T Committee, other entities within the University, as needed for SOC, as well as clinical trial study sponsors external to the University.

Work Location

Hybrid – eligible for a hybrid schedule of 2–3 days per week on campus and as needed for in-person meetings upon successful training and with approval of management.

Why Join Us

As an academic based biotechnology company, ClinImmune is committed to providing the highest quality service and support to clinical customers and researchers locally and abroad. Our prime location at the University of Colorado Anschutz Medical Campus allows for collaboration with world-renowned clinicians and scientists. ClinImmune is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

We have amazing benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including :

Qualifications

Minimum Qualifications :

Preferred Qualifications :

Knowledge, Skills, and Abilities

Conditions of Employment

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, with minimal supervision and critical thinking. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

How to Apply

For full consideration, please submit the following document(s) :

Questions should be directed to Sandra Fradenburg, sandra.fradenburg@cuanschutz.edu.

Application Deadline

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 15th, 2025 . Those who do not apply by this date may or may not be considered.

Anticipated Pay Range

The starting salary range for this position has been established as $91,488 – $115,935.

Equal Employment Opportunity Statement

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process.

Background Check Statement

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine-preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively.

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