Regulatory Affairs Specialists

Edtech.com's Summary

University of Utah is hiring a Regulatory Affairs Specialist (QA/QC Navigator) to support the Utah Clinical & Translational Science Institute (CTSI). The specialist will oversee and improve processes ensuring compliance with NIH and NCATS policies, including prior approval submissions, ClinicalTrials.gov requirements, and the NIH Public Access Policy, while collaborating with various internal and external stakeholders.

Highlights

Manage prior approval processes for human and animal studies and assist investigators with regulatory submissions.

Collaborate with University of Utah’s Office of Quality Compliance and NCATS QA/QC working group for compliance adherence.

Support compliance with ClinicalTrials.gov registration, updates, and results reporting.

Ensure adherence to NIH Public Access Policy and assist authors with related procedures.

Work with the Continuous Improvement, Tracking, and Evaluation (CITE) team to collect and report program outcomes.

Required qualifications vary by level: Regulatory Affairs Specialist I requires a bachelor’s plus 2 years relevant experience or a master’s degree; Specialist II requires a bachelor’s plus 4 years or master’s plus 2 years experience.

Preferred experience includes human subjects research understanding, clinical trials/research experience, and regulatory knowledge.

Salary range provided: $43,945 - $62,527 annually.

Full-time, professional position with typical business hours and benefits such as retirement contributions and medical coverage.

Position involves continuous office work, including sitting, talking, and moderate computer use.

Regulatory Affairs Specialists Full Description

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Regulatory Affairs Specialists Bookmark this Posting Print Preview | Apply for this Job

Please see Special Instructions for more details.

In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.

Announcement

Details

Open Date	04/30/2026
Requisition Number	PRN44883B
Job Title	Regulatory Affairs Specialists
Working Title	QA/QC Navigator
Career Progression Track	P00
Track Level	P2 - Developing, P1 - Entry Level Pro
FLSA Code	Professional
Patient Sensitive Job Code?	No
Standard Hours per Week	40
Full Time or Part Time?	Full Time
Shift	Day
Work Schedule Summary	Arranged with supervisor; typically M-F 8-5 standard business hours
VP Area	U of U Health - Academics
Department	00212 - Ctr Clin & Translational Sc.
Location	Campus
City	Salt Lake City, UT
Type of Recruitment	External Posting
Pay Rate Range	$43,945 - $62,527
Close Date	06/30/2026
Priority Review Date (Note - Posting may close at any time)
Job Summary	The Utah Clinical & Translational Science Institute (CTSI) is seeking a Quality Assurance/Quality Control navigator (QA/QC) to join our team! The CTSI is funded by the National Center for Advancing Translational Science (NCATS) to provide research resources, training, and pilot funding to advance human health. As a result of this federal funding, the CTSI and its programs and pilot grants must comply with the policies set by NCATS and the National Institute of Health (NIH). As part of the CTSI’s grants team, and working in close collaboration with the University of Utah’s Office of Quality Compliance and the NCATS QA/QC working group, the QA/QC navigator will help the CTSI maintain compliance with NIH policies. They will oversee processes to ensure compliance with annual reporting requirements, prior approval processes, ClinicalTrials.gov requirements, and the NIH Public Access Policy. In addition, they will lead efforts to 1) improve and streamline processes and programming that promote compliance and 2) to create best practices for consistency, efficiency, and effectiveness. Click here to learn more about the CTSI Learn more about the fantastic benefits provided to University of Utah Employees including generous retirement contribution, comprehensive medical coverage, tuition reduction, and more. In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
Responsibilities	Essential Functions: Work closely with internal and external stakeholders to complete and improve the prior approval process (human and animal studies), including ongoing progress reporting as required by NCATS. For new pilot and other projects, help investigators prepare prior approval submissions to ensure the projects are in compliance with NIH policies before they begin. Provide IRB (including single IRB) and IACUC assistance as needed to internal project investigators. Work closely with the CTSI’s Continuous Improvement, Tracking, and Evaluation (CITE) team to collect and report outcomes metrics on our various programs as required by NCATS. Participate in the NCATS QA/QC working group and subcommittees to improve and streamline the prior approval processes and other QA/QC processes. The QA/QC navigator will be expected to take the feedback from the Utah CTSI community to these meetings with the purpose of making a QA/QC plan, shaping improvements, and developing milestones and metrics for performance enhancement. Provide support to the CTSI to 1) ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI, including assisting authors with the process, and 2) develop and refine programming (web materials, presentations, etc) to promote awareness of this requirement throughout the timeline of an investigator/author’s involvement with any CTSI core(s). This process will ensure that the scientific innovations stemming from the CTSI are shared publicly to promote dissemination. Provide support to the CTSI to ensure compliance with ClinicalTrials.gov requirements, including study registration, updates, and results reporting. Other duties as identified. Note: This position is not responsible for providing patient care. Problem Solving This position will utilize federal, institutional guidelines and requirements, and best practices to complete prior approval submissions and work collaboratively to improve the processes. This position will also work with University research committees and NCATS to ensure full compliance and communication. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead. Applicants will be hired into one of two levels depending on experience: Regulatory Affairs Specialists, 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) + 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: P21911 Grade: P13 Regulatory Affairs Specialists, 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: P21912 Grade: P16
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 Specialists, I: Requires a bachelor’s (or equivalency) + 2 years of directly related work experience or a master’s (or equivalency) degree. Regulatory Affairs Specialists, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.
Preferences	A demonstrated understanding of human subjects research, regulatory documents, and quality compliance is strongly preferred. Familiarity with animal research is also helpful. At least two years clinical trials/research experience strongly preferred. One year of regulatory experience, an understanding of medical terminology, and technical writing experience preferred. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through.
Type	Benefited Staff
Special Instructions Summary	In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
Additional Information	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.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

* What is your highest level of completed education?
- None
- High School Diploma or Equivalent
- Associate Degree
- Bachelor's Degree
- Master's Degree
- Doctorate Degree
* How many years of related work experience do you have?
- Less than 2 years
- 2 years or more, but less than 4 years
- 4 years or more, but less than 6 years
- 6 years or more, but less than 8 years
- 8 years or more, but less than 10 years
- 10 years or more, but less than 12 years
- 12 years or more, but less than 14 years
- 14 years or more

Applicant Documents

Required Documents

Resume
Cover Letter

Optional Documents

University Human Resource Management
250 East 200 South, Suite 125 Salt Lake City, UT 84111
Contact us: (801) 581-2169 By Email: employment@utah.edu

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Original Job Description

Toggle navigation

Regulatory Affairs Specialists Bookmark this Posting Print Preview | Apply for this Job

Please see Special Instructions for more details.

In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.

Announcement

Details

Open Date	04/30/2026
Requisition Number	PRN44883B
Job Title	Regulatory Affairs Specialists
Working Title	QA/QC Navigator
Career Progression Track	P00
Track Level	P2 - Developing, P1 - Entry Level Pro
FLSA Code	Professional
Patient Sensitive Job Code?	No
Standard Hours per Week	40
Full Time or Part Time?	Full Time
Shift	Day
Work Schedule Summary	Arranged with supervisor; typically M-F 8-5 standard business hours
VP Area	U of U Health - Academics
Department	00212 - Ctr Clin & Translational Sc.
Location	Campus
City	Salt Lake City, UT
Type of Recruitment	External Posting
Pay Rate Range	$43,945 - $62,527
Close Date	06/30/2026
Priority Review Date (Note - Posting may close at any time)
Job Summary	The Utah Clinical & Translational Science Institute (CTSI) is seeking a Quality Assurance/Quality Control navigator (QA/QC) to join our team! The CTSI is funded by the National Center for Advancing Translational Science (NCATS) to provide research resources, training, and pilot funding to advance human health. As a result of this federal funding, the CTSI and its programs and pilot grants must comply with the policies set by NCATS and the National Institute of Health (NIH). As part of the CTSI’s grants team, and working in close collaboration with the University of Utah’s Office of Quality Compliance and the NCATS QA/QC working group, the QA/QC navigator will help the CTSI maintain compliance with NIH policies. They will oversee processes to ensure compliance with annual reporting requirements, prior approval processes, ClinicalTrials.gov requirements, and the NIH Public Access Policy. In addition, they will lead efforts to 1) improve and streamline processes and programming that promote compliance and 2) to create best practices for consistency, efficiency, and effectiveness. Click here to learn more about the CTSI Learn more about the fantastic benefits provided to University of Utah Employees including generous retirement contribution, comprehensive medical coverage, tuition reduction, and more. In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
Responsibilities	Essential Functions: Work closely with internal and external stakeholders to complete and improve the prior approval process (human and animal studies), including ongoing progress reporting as required by NCATS. For new pilot and other projects, help investigators prepare prior approval submissions to ensure the projects are in compliance with NIH policies before they begin. Provide IRB (including single IRB) and IACUC assistance as needed to internal project investigators. Work closely with the CTSI’s Continuous Improvement, Tracking, and Evaluation (CITE) team to collect and report outcomes metrics on our various programs as required by NCATS. Participate in the NCATS QA/QC working group and subcommittees to improve and streamline the prior approval processes and other QA/QC processes. The QA/QC navigator will be expected to take the feedback from the Utah CTSI community to these meetings with the purpose of making a QA/QC plan, shaping improvements, and developing milestones and metrics for performance enhancement. Provide support to the CTSI to 1) ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI, including assisting authors with the process, and 2) develop and refine programming (web materials, presentations, etc) to promote awareness of this requirement throughout the timeline of an investigator/author’s involvement with any CTSI core(s). This process will ensure that the scientific innovations stemming from the CTSI are shared publicly to promote dissemination. Provide support to the CTSI to ensure compliance with ClinicalTrials.gov requirements, including study registration, updates, and results reporting. Other duties as identified. Note: This position is not responsible for providing patient care. Problem Solving This position will utilize federal, institutional guidelines and requirements, and best practices to complete prior approval submissions and work collaboratively to improve the processes. This position will also work with University research committees and NCATS to ensure full compliance and communication. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead. Applicants will be hired into one of two levels depending on experience: Regulatory Affairs Specialists, 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) + 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: P21911 Grade: P13 Regulatory Affairs Specialists, 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: P21912 Grade: P16
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 Specialists, I: Requires a bachelor’s (or equivalency) + 2 years of directly related work experience or a master’s (or equivalency) degree. Regulatory Affairs Specialists, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.
Preferences	A demonstrated understanding of human subjects research, regulatory documents, and quality compliance is strongly preferred. Familiarity with animal research is also helpful. At least two years clinical trials/research experience strongly preferred. One year of regulatory experience, an understanding of medical terminology, and technical writing experience preferred. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through.
Type	Benefited Staff
Special Instructions Summary	In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
Additional Information	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.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

* What is your highest level of completed education?
- None
- High School Diploma or Equivalent
- Associate Degree
- Bachelor's Degree
- Master's Degree
- Doctorate Degree
* How many years of related work experience do you have?
- Less than 2 years
- 2 years or more, but less than 4 years
- 4 years or more, but less than 6 years
- 6 years or more, but less than 8 years
- 8 years or more, but less than 10 years
- 10 years or more, but less than 12 years
- 12 years or more, but less than 14 years
- 14 years or more

Applicant Documents

Required Documents

Resume
Cover Letter

Optional Documents

University Human Resource Management
250 East 200 South, Suite 125 Salt Lake City, UT 84111
Contact us: (801) 581-2169 By Email: employment@utah.edu

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Regulatory Affairs Specialists

Edtech.com's Summary

Regulatory Affairs Specialists Full Description

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