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), IRequires
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),
IIRequires 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),
IIIConsidered 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),
IVRecognized 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: PZ6894Grade: P17Expected Pay Range: $68,204 to $92,678
Disclaimer: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.
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).
Department may hire employee at one of the following job
levels:
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
Preferences:
- Experience with University of Utah IRB.
- Clinical research regulatory experience.
- CITI Training (or to be completed within 1 month of hire).
The Department will screen applicants according to the
identified preferences.
Special Instructions
Requisition Number: PRN45245B
Full Time or Part Time? Full Time
Work Schedule Summary: 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.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: Depends on Experience
Close Date: 09/03/2026
Open Until Filled:
To apply, visit https://apptrkr.com/9745863"">https://utah.peopleadmin.com/postings/203047
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