Regulatory Affairs Supervisor

Regulatory Affairs Supervisor - 40134  University Staff  Description   University of Colorado Anschutz Medical Campus Department: Cancer Center Working Title: Regulatory Affairs Supervisor Position #: 697586 – Requisition #: 40134 Job Summary: This position oversees their regulatory unit in the Cancer Clinical Trials Office (CCTO) and directly supervises their assigned regulatory unit staff.

The Regulatory Research Supervisor ensures regulatory compliance for clinical research studies, provides leadership and mentorship to regulatory personnel, and collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials.

The position also contributes to quality assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert within the CCTO.

Responsabilidades

: 50% Supervisory - Training/Mentorship/Workload Management · Assures adherence within their regulatory unit to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies

Arranges orientation and provides training, supervision, and mentorship to their regulatory unit.

Supervises vacation, out of office coverage, and time management of direct reports.

Makes recommendations regarding regulatory personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager.

This would include letters of expectations being written and delivered to direct reports.

Monitors workload acuity with guidance from the Regulatory Manager.

· Assists regulatory specialists with technical issues, problem solving and intervention when appropriate.

Answers questions from regulatory team including but not limited to processes, guidance documents, sponso.