Regulatory Affairs Specialists (Life Sciences)

Regulatory Affairs Specialist (Life Sciences) Job Summary: 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 position is responsible for preparing, submitting, and tracking regulatory documents to ensure compliance with institutional, federal, and sponsor requirements. The Regulatory Affairs Specialist will collaborate with study teams, institutional review boards (IRB), and external sponsors to support study start‑up, maintenance, and closeout activities. The role involves maintaining regulatory documentation, supporting audits and inspections, and ensuring adherence to applicable regulations and guidelines. The incumbent will also assist in monitoring regulatory changes and communicating updates to study teams to support ongoing compliance. Department Summary: 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. We are 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. Ensure submissions are complete, timely, and regulatory objectives are met. 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 of pending registration. Compile materials required for submissions, license renewals, and annual registrations. Identify relevant guidance documents and interpret international/consensus standards. Participate in internal and 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 as needed to support compliance and operational objectives. Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience). Regulatory Affairs Specialist (Life Sciences), I: Requires a bachelor’s (or equivalency) + 2 years of directly related work experience or a master’s (or equivalency) degree. Regulatory Affairs Specialist (Life Sciences), II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Regulatory Affairs Specialist (Life Sciences), III: Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. Regulatory Affairs Specialist (Life Sciences), IV: Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience. Preferences Experience with University of Utah IRB. Clinical research regulatory experience. CITI Training (or to be completed within one month of hire). Benefits Summary Health care coverage at affordable rates. 14.2% retirement contributions. Generous paid leave time. 11 paid holidays per year. 50% tuition reduction for employees, spouses, and dependent children. Flex spending accounts. Basic employee life insurance coverage equal to a salary of up to $25,000. Elective insurance coverage, including life insurance, short and long‑term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet. Free transit on most UTA services. Employee discounts on a variety of products and services. Professional development opportunities. Employee Health Requirements This position is patient‑sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient‑sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Equal Employment Opportunity Statement Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy‑related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator or the Department of Education Office for Civil Rights. #J-18808-Ljbffr University of Utah