Regulatory Specialist
The Division of Neurology in the Department of Pediatrics is seeking a Regulatory Affairs Specialist to support clinical research activities at the University of Utah Spencer F. Eccles School of Medicine. This role involves preparing, submitting, and tracking regulatory documents to ensure compliance with institutional, federal, and sponsor requirements.
About the Department
The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. The department is committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. Mutual respect and appreciation are highly valued in the department.
Responsibilities
- Prepare, submit, and track regulatory documents and submissions to ensure completeness, timeliness, and compliance with regulatory objectives.
- Research scientific and regulatory information to write, edit, and review reports.
- Work with governmental and regulatory bodies (e.g., FDA, MHRA, EMA) to ensure compliance and expedite approvals.
- Compile materials required for submissions, license renewals, and annual registrations.
- Identify relevant guidance documents and interpret international/consensus standards.
- Participate in internal or external audits and inspections.
- Prepare and submit IRB applications, amendments, and reports to support study start-up and ongoing compliance.
- Track IRB submissions, complete required revisions, and ensure adherence to established timelines.
- Prepare and maintain study training logs and regulatory documentation (e.g., DOA logs).
- Manage and maintain regulatory binders/ISF and associated study documentation.
- Ensure all regulatory documents, certifications, and licenses are current and maintained.
- Monitor updates to University of Utah IRB policies and processes and apply changes to study activities.
- Communicate regulatory and IRB updates to study teams to ensure ongoing compliance.
- Review and maintain familiarity with active study protocols to support regulatory requirements.
- Collaborate with study teams and sponsors to finalize regulatory documents (e.g., ICFs).
- Ensure timely completion of regulatory submissions and revisions in accordance with study timelines.
- Assist in the development and maintenance of internal SOPs, as needed.
- Assist with additional regulatory or study-related tasks to support compliance and operational objectives.
Requirements
This position is posted at multiple job levels, with distinct qualifications and responsibilities evaluated during the selection process. Final placement, including pay rate, will be determined based on business needs and budget considerations.
- Regulatory Affairs Specialist (Life Sciences), I: Requires a bachelor's degree (or equivalency) with up to 2 years of directly related work experience or a master's degree (or equivalency).
- Regulatory Affairs Specialist (Life Sciences), II: Requires a bachelor's degree (or equivalency) with 4 years or a master's degree (or equivalency) with 2 years of directly related work experience.
- Regulatory Affairs Specialist (Life Sciences), III: Requires a bachelor's degree (or equivalency) with 6 years or a master's degree (or equivalency) with 4 years of directly related work experience.
- Regulatory Affairs Specialist (Life Sciences), IV: Requires a bachelor's degree (or equivalency) with 8 years or a master's degree (or equivalency) with 6 years of directly related work experience.
One year of higher education can be substituted for one year of directly related work experience.
Preferences
- Experience with University of Utah IRB.
- Clinical research regulatory experience.
- CITI Training (or willingness to complete within 1 month of hire).
Benefits
- Comprehensive health care coverage at affordable rates.
- 14.2% retirement contributions.
- Generous paid leave time and 11 paid holidays per year.
- 50% tuition reduction for employees, spouses, and dependent children.
- University-provided basic employee life insurance coverage equal to a salary of up to $25,000.
- Variety of elective insurance coverage options, including life insurance, short- and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet insurance.
- Free transit on most UTA services.
- Employee discounts on products and services, including cell phones, entertainment, health and fitness, restaurants, retail, and travel.
- Professional development opportunities.
Pay
- Regulatory Affairs Specialist I: $46,584 to $57,976
- Regulatory Affairs Specialist II: $51,242 to $69,629
- Regulatory Affairs Specialist III: $62,004 to $84,252
- Regulatory Affairs Specialist IV: $68,204 to $92,678
Schedule
Full-time position, Monday – Friday, 8:00 a.m. – 5:00 p.m. Hours may vary based on operational needs. Opportunities for a hybrid telework schedule may be considered after the initial training period, provided the arrangement is supported by operational needs and individual performance.
Employee Health Requirements
This position is patient-sensitive and requires fulfillment of all associated vaccination requirements, or approval for an exemption, prior to the first day of work. Immunizations are required according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.