Details

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. Telework arrangements are not guaranteed and may be modified or discontinued at any time based on business requirements or performance. Employees approved for hybrid telework must provide their own private workspace, secure internet connection, and demonstrate the ability to work independently.

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.

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.

The University of Utah offers a comprehensive benefits package including:

Additional benefits information is available at https://benefits.utah.edu/.

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.

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.

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: PZ6891

Grade: P13

Expected Pay Range: $46,584 to $57,976

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: PZ6892

Grade: P14

Expected Pay Range: $51,242 to $69,629

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: PZ6893

Grade: P16

Expected Pay Range: $62,004 to $84,252

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.

Job Code: PZ6894

Grade: P17

Expected Pay Range: $68,204 to $92,678

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education.

Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

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, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX ( OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page

Online reports may be submitted at https://oeo.utah.edu


https://publicsafety.utah.edu/safetyreport/ This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.