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Regulatory Specialist
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University of Utah
Salt Lake City, UT (In Person)
$52,280 Salary, Full-Time
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Job Description
Regulatory Specialist Job Summary 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. This position is posted at multiple job levels. Each level has distinct qualifications, responsibilities, which will be evaluated during the selection process. Final placement, including the associated pay rate, will be determined based on business needs and budget considerations.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. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/ . Mutual respect and appreciation are highly valued in the department.Benefits Summary:
The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates (see the Summary Comparison for more information) 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 University provided basic employee life insurance coverage equal to a salary of up to $25,000 Variety of 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, including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel Professional development opportunities Additional benefits information is available at https://benefits.utah.edu/ .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.Responsibilities Essential Functions:
Prepare, submit, and track regulatory documents and submissions. Ensure submissions are complete, timely, and regulatory objectives are met. Research scientific and regulatory information in order to write, edit, and review reports. Work with various governmental and regulatory bodies (e.g., FDA, MHRA, EMA) to ensure compliance and expedite approval of pending registration. Compile all material 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. 1. Prepare and submit IRB applications, amendments, and reports to support study start-up and ongoing compliance.2. Track IRB submissions, complete required revisions, and ensure adherence to established timelines.3. Prepare and maintain study training logs and regulatory documentation (e.g., DOA logs).4. Manage and maintain regulatory binders/ISF and associated study documentation.5. Ensure all regulatory documents, certifications, and licenses are current and maintained.6. Monitor updates to University of Utah IRB policies and processes and apply changes to study activities.7. Communicate regulatory and IRB updates to study teams to ensure ongoing compliance.8. Review and maintain familiarity with active study protocols to support regulatory requirements.9. Collaborate with study teams and sponsors to finalize regulatory documents (e.g., ICFs).10. Ensure timely completion of regulatory submissions and revisions in accordance with study timelines.11. Assist in the development and maintenance of internal SOPs, as needed.12. Assist with additional regulatory or study-related tasks as needed to support compliance and operational objectives. The following job levels and associated pay rates will be considered based on job placement. Final placement, including the corresponding pay rate, will be determined by the department in alignment with business needs and budget considerations. Regulatory Affairs Specialist (Life Sciences), I Requires basic skill set and proficiency. Conducts work assignments as directed. Closely supervised with little latitude for independent judgment. Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree.This is an Entry-Level position in the General Professional track.
Job Code:
PZ6891Grade:
P13Expected Pay Range:
$46,584 to $57,976 Regulatory Affairs Specialist (Life Sciences), II Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment. Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.This is a Developing-Level position in the General Professional track.
Job Code:
PZ6892Grade:
P14Expected Pay Range:
$51,242 to $69,629 Regulatory Affairs Specialist (Life Sciences), III Considered highly skilled and proficient in discipline. Conducts complex, important work under minimal supervision and with wide latitude for independent judgment. Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience.This is a Career-Level position in the General Professional track.
Job Code:
PZ6893Grade:
P16Expected Pay Range:
$62,004 to $84,252 Regulatory Affairs Specialist (Life Sciences), IV Recognized as subject matter expert and advanced individual contributor professional. Requires specialized skill set. Conducts highly complex work, unsupervised and with extensive latitude for independent judgment. Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience.This is an Advanced-Level position in the General Professional track.