Regulatory Affairs Supervisor

Job Overview

Regulatory Affairs Supervisor - 40134 University Staff 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.

Job Description

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

Arranges orientation and provides training, supervision, and mentorship to their regulatory unit. Supervises vacation, out of office coverage, and time management of direct reports.

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, sponsor/ monitor questions, approval committee queries, and department logistics.

Key Responsibilities

• 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.
• Key Responsibilities : 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.
• 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.
• 40% Leadership/Compliance/Process Improvement As part of the regulatory leadership team, collaborates with other Regulatory Supervisors and Regulatory Managers to identify team challenges, solutions, and improvement ideas.
• Collaborates with Clinical Research Managers to ensure protocol amendments are processed in an efficient and timely manner.

Required Skills and Qualifications

• · Ensures required timelines are met for submission, approval and distribution of protocol amendments, consent revisions and all applicable protocol specific documents for their regulatory unit.
• This benefit must be approved by your supervisor.
• As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control.
• To see what benefits are available, please visit: Qualifications: Minimum Qualifications: Education: Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.
• Experience: Three (3) years of clinical research experience, with at least 2 of those 3 years in regulatory affairs.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
• Applicants must meet minimum qualifications at the time of application.
• Applicants must be legally authorized to work in the United States without requiring sponsorship.

Benefits and Perks

• Regulatory Affairs Supervisor - 40134 University Staff 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.
• Supervises vacation, out of office coverage, and time management of direct reports.
• This benefit must be approved by your supervisor.
• We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave!
• The University of Colorado offers an excellent benefits package including: Medical: Multiple plan options Dental: Multiple plan options Additional Insurance: Disability, Life, Vision Retirement 401(a) Plan: Employer contributes 10% of your gross pay Paid Time Off: Accruals over the year Vacation Days: 22/year (maximum accrual 352 hours) Sick Days: 15/year (unlimited maximum accrual) Holiday Days: 10/year Tuition Benefit: Employees have access to this benefit on all CU campuses ECO Pass: Reduced rate RTD Bus and light rail service There are many additional perks & programs with the CU Advantage .
• To see what benefits are available, please visit: Qualifications: Minimum Qualifications: Education: Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.

Work Location and Schedule

This role is listed as Remote USA with location information shown as Remote USA. The employment type is Full Time.

About the Company

University of Colorado is the organization connected with this listing. USA Jobs Today displays this opportunity for job discovery only, so applicants should verify company details, application instructions, and eligibility on the official employer website.