Regulatory Affairs Supervisor

1h1 hour ago

University of Colorado Anschutz Medical Campus

Aurora, US · Full-time · $71,517 – $90,970

About this role

This position oversees the regulatory unit within the Cancer Clinical Trials Office (CCTO) and directly supervises assigned regulatory staff. The Regulatory Research Supervisor ensures compliance with FDA, OHRP, and NCI standards while providing leadership and mentorship to regulatory personnel.

Day-to-day responsibilities include monitoring workload acuity, arranging orientation and training, and supervising time management and coverage for direct reports. The supervisor also assists regulatory specialists with technical issues, problem-solving, and intervention when needed, answering questions about processes, guidance documents, and approval committees.

Working within the CCTO, this role collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials. The supervisor contributes to quality assurance and process improvement initiatives, serving as a regulatory subject matter expert across the office.

This position offers the opportunity to shape regulatory operations within a leading academic medical campus. There is potential for growth through involvement in operational initiatives and mentorship of developing regulatory professionals.

Requirements

Knowledge of FDA regulations for clinical trials, including those governing investigational new drugs.
Understanding of OHRP and NCI guidelines for human subjects research and cancer clinical trials.
Experience in regulatory compliance or regulatory affairs within a clinical research setting.
Supervisory or team lead experience, including hiring, performance evaluations, and disciplinary actions.
Ability to train and mentor regulatory staff on complex submission processes.
Proven problem-solving skills and ability to intervene on technical regulatory issues.
Familiarity with IRB and institutional review processes for oncology trials.

Responsibilities

Assure adherence to all research standards set by FDA, OHRP, University of Colorado Hospital, UCD, NCI, and other pertinent regulatory agencies.
Arrange orientation and provide training, supervision, and mentorship to regulatory unit staff.
Supervise vacation, out-of-office coverage, and time management of direct reports.
Monitor workload acuity with guidance from the Regulatory Manager.
Assist regulatory specialists with technical issues, problem solving, and intervention when appropriate.
Answer questions from the regulatory team regarding processes, guidance documents, sponsor/monitor inquiries, approval committee queries, and department logistics.
Ensure required timelines are met for submission, approval, and distribution of protocol amendments and other regulatory documents.