Regulatory Specialist

Job Summary The Division of Neurology in the Department of Pediatrics seeks a Regulatory Affairs Specialist to support clinical research activities at the University of Utah Spencer F. Eccles School of Medicine. This role is responsible for preparing, submitting, and tracking regulatory documents to ensure compliance with institutional, federal, and sponsor requirements. The Specialist collaborates with study teams, IRBs, and external sponsors to support study start‑up, maintenance, and closeout activities. Responsibilities Prepare, submit, and track regulatory documents and submissions; ensure they are complete, timely, and meet 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 approval. Compile material required for submissions, license renewals, and annual registrations. Identify relevant guidance documents and interpret international/con consensus standards. Participate in internal or external audits and inspections. Prepare and submit IRB applications, amendments, and reports to support study start‑up. Track IRB submissions, complete required revisions, and adhere to established timelines. Prepare and maintain study training logs and regulatory documentation (e.g., DOA logs). Manage and maintain regulatory binders/ISFs and associated study documentation. Ensure all regulatory documents, certifications, and licenses are current. Monitor updates to University of Utah IRB policies and processes and apply changes to study activities. Communicate regulatory and IRB updates to study teams. Review study protocols to support regulatory requirements. Collaborate with study teams and sponsors to finalize documents (e.g., ICFs). Ensure timely completion of regulatory submissions and revisions in accordance with study timelines. Assist in developing and maintaining internal SOPs as needed. Assist with additional regulatory or study‑related tasks as required. Minimum Qualifications Equivalency Statement: 1 year of higher education can substitute for 1 year of directly related work experience. Education: Bachelor’s degree (or equivalency) with at least 2 years of directly related work experience, or master’s degree with appropriate experience for the desired level. Experience: Up to 8 years of directly related work experience depending on level (I: 2 years, II: 4 years, III: 6 years, IV: 8 years). Preferred Experience: University of Utah IRB experience, clinical research regulatory experience, CITI training. Job Levels and Pay Ranges Regulatory Affairs Specialist (Life Sciences), I – Grade P13 – $46,584 to $57,976 Regulatory Affairs Specialist (Life Sciences), II – Grade P14 – $51,242 to $69,629 Regulatory Affairs Specialist (Life Sciences), III – Grade P16 – $62,004 to $84,252 Regulatory Affairs Specialist (Life Sciences), IV – Grade P17 – $68,204 to $92,678 EEO Statement The University of Utah does not discriminate based on race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, gender expression, pregnancy, genetic information, or protected veteran’s status. All qualified applicants will receive consideration for employment. #J-18808-Ljbffr University of Utah Health