Regulatory Affairs Specialists

Edtech.com's Summary

University of Utah is hiring a Regulatory Affairs Specialist. The role involves serving as the regulatory lead for Utah Data Coordinating Center projects, preparing regulatory documents, ensuring compliance with regulatory requirements, researching regulatory changes, and providing recommendations on emerging regulatory issues. The position supports multi-site research through collaboration, critical thinking, and regulatory expertise.

Highlights

Serve as the regulatory lead for assigned projects, providing strategic input throughout study planning, execution, and reporting.

Lead interactions with the FDA and other regulatory agencies, including preparation and participation in regulatory meetings.

Develop, implement, and maintain SOPs, templates, and regulatory processes to support organizational growth.

Ensure audit readiness and compliance with GCP, ICH, and FDA regulations for clinical studies.

Draft, review, and finalize regulatory submissions such as INDs, amendments, and clinical study reports.

Provide regulatory training and mentorship to team members and cross-functional partners.

Stay current with evolving US and global regulatory requirements and communicate updates to leadership and teams.

Required qualifications vary by level, including bachelor’s or master’s degree plus relevant experience ranging from 2 to 8+ years.

Preferences include advanced degrees, global regulatory experience, in-depth knowledge of ICH GCP and FDA guidelines, and direct FDA interaction experience.

Pay range: $50,909 to $112,978 depending on job level and experience.

Regulatory Affairs Specialists Full Description

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Announcement

Details

Open Date	02/05/2026
Requisition Number	PRN44203B
Job Title	Regulatory Affairs Specialists
Working Title	Regulatory Affairs Specialists
Career Progression Track	P00
Track Level	P4 - Advanced, P3 - Career, P2 - Developing
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	Full-time, 40 hours per week. Monday – Friday
VP Area	U of U Health - Academics
Department	02228 - Data Coordinating Center
Location	Campus
City	Salt Lake City, UT
Type of Recruitment	External Posting
Pay Rate Range	50,909 to 112,978
Close Date	05/05/2026
Priority Review Date (Note - Posting may close at any time)
Job Summary	Regulatory Affairs Specialists Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. This position is in the Utah Data Coordinating Center. Join the Utah DCC where we harness the power of collaboration, to advance science, move society, and benefit humanity. We offer opportunities to work with high functioning, cutting-edge teams that study, understand, and improve multi-site research. Bring your strong background in regulatory affairs to the Utah DCC. Autonomy, creativity, and critical thinking skills are strongly encouraged. The Utah DCC offers a career ladder for this position and provides growth and professional development opportunities. Learn more about the Utah DCC: https://uofuhealth.utah.edu/utah-dcc Learn more about the great benefits of working at the University of Utah: https://benefits.utah.edu/ This is posted as open-rank and may be filled at any of the listed job levels. Work Schedule Summary Full-time, 40 hours per week. Monday – Friday Work Location & Residency Residency in the State of Utah is preferred. This position offers a flexible, mostly remote work schedule for candidates who reside in the State of Utah. While most duties can be performed remotely, the employee must be available to attend essential meetings and events on campus as needed. Out of state applicants will be considered. Hiring is contingent upon an out of state approval at the institutional level. Travel This position may require occasional travel.
Responsibilities	Job Responsibilities and Essential Functions Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. Serve as the regulatory lead for assigned projects, providing strategic input throughout study planning, execution, and reporting. Provide strategic leadership for interactions with the FDA and other regulatory agencies, including preparation for and participation in regulatory meetings. Develop, implement, and maintain Standard Operating Procedures (SOPs), templates, and regulatory processes to support organizational growth. Ensure audit readiness for all clinical studies by developing processes that ensure compliance with GCP, ICH, and FDA regulations. Draft, review, and finalize regulatory submissions as appropriate (e.g., INDs, amendments, annual reports, clinical study reports). Contribute to the development and review of key study documents, including clinical protocols, informed consent forms, and clinical study reports. Provide regulatory training and mentorship to team members and cross-functional partners. Serve as a regulatory resource to study teams, as appropriate. Critically evaluate the regulatory strategy of potential partners/customers and provide feedback to colleagues within the University of Utah, as appropriate. Stay current with evolving US and global regulatory requirements, proactively communicating relevant updates to leadership and project teams. Conduct staff training sessions on regulatory affairs topics. Department intends to fill one vacancy and may choose to fill at any of the below job levels dependent on business needs and budget. 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. Expected Pay Range: $50,909 to $77,166 Regulatory Affairs Specialists, 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. Expected Pay Range: $61,599 to $93,370 Regulatory Affairs Specialists, 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. Expected Pay Range: $74,535 to $112,978
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, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Regulatory Affairs Specialists, III: Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. Regulatory Affairs Specialists, IV: Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience.
Preferences	Preferences Advanced degree (MS, PharmD, PhD, MD). Global regulatory experience. Deep understanding of ICH GCP, FDA, and international regulatory guidelines. Proven ability to lead regulatory strategy and execution for complex clinical programs Bachelor’s degree in life sciences, regulatory affairs, or related field. Minimum 10 years’ regulatory affairs experience within a regulatory agency (e.g., FDA), or in the pharmaceutical, biotechnology, or CRO industry. Demonstrated experience interacting directly with the FDA and/or other regulatory authorities. Strong knowledge of US regulatory requirements (e.g., IND, IDE, emergency IND, NDA, etc.). Excellent scientific writing and document review skills. Strong organizational skills with the ability to manage multiple projects and priorities. High attention to detail and commitment to quality. Applicants will be screened according to preferences.
Type	Benefited Staff
Special Instructions Summary
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: https://www.utah.edu/nondiscrimination/ Online reports may be submitted at oeo.utah.edu https://safety.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.

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
* Will you now or in the future require sponsorship for employment visa status (e.g., H-1B status)?
- Yes
- No
* Are you legally authorized to work in the United States?
- Yes
- No

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

Announcement

Details

Open Date	02/05/2026
Requisition Number	PRN44203B
Job Title	Regulatory Affairs Specialists
Working Title	Regulatory Affairs Specialists
Career Progression Track	P00
Track Level	P4 - Advanced, P3 - Career, P2 - Developing
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	Full-time, 40 hours per week. Monday – Friday
VP Area	U of U Health - Academics
Department	02228 - Data Coordinating Center
Location	Campus
City	Salt Lake City, UT
Type of Recruitment	External Posting
Pay Rate Range	50,909 to 112,978
Close Date	05/05/2026
Priority Review Date (Note - Posting may close at any time)
Job Summary	Regulatory Affairs Specialists Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. This position is in the Utah Data Coordinating Center. Join the Utah DCC where we harness the power of collaboration, to advance science, move society, and benefit humanity. We offer opportunities to work with high functioning, cutting-edge teams that study, understand, and improve multi-site research. Bring your strong background in regulatory affairs to the Utah DCC. Autonomy, creativity, and critical thinking skills are strongly encouraged. The Utah DCC offers a career ladder for this position and provides growth and professional development opportunities. Learn more about the Utah DCC: https://uofuhealth.utah.edu/utah-dcc Learn more about the great benefits of working at the University of Utah: https://benefits.utah.edu/ This is posted as open-rank and may be filled at any of the listed job levels. Work Schedule Summary Full-time, 40 hours per week. Monday – Friday Work Location & Residency Residency in the State of Utah is preferred. This position offers a flexible, mostly remote work schedule for candidates who reside in the State of Utah. While most duties can be performed remotely, the employee must be available to attend essential meetings and events on campus as needed. Out of state applicants will be considered. Hiring is contingent upon an out of state approval at the institutional level. Travel This position may require occasional travel.
Responsibilities	Job Responsibilities and Essential Functions Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. Serve as the regulatory lead for assigned projects, providing strategic input throughout study planning, execution, and reporting. Provide strategic leadership for interactions with the FDA and other regulatory agencies, including preparation for and participation in regulatory meetings. Develop, implement, and maintain Standard Operating Procedures (SOPs), templates, and regulatory processes to support organizational growth. Ensure audit readiness for all clinical studies by developing processes that ensure compliance with GCP, ICH, and FDA regulations. Draft, review, and finalize regulatory submissions as appropriate (e.g., INDs, amendments, annual reports, clinical study reports). Contribute to the development and review of key study documents, including clinical protocols, informed consent forms, and clinical study reports. Provide regulatory training and mentorship to team members and cross-functional partners. Serve as a regulatory resource to study teams, as appropriate. Critically evaluate the regulatory strategy of potential partners/customers and provide feedback to colleagues within the University of Utah, as appropriate. Stay current with evolving US and global regulatory requirements, proactively communicating relevant updates to leadership and project teams. Conduct staff training sessions on regulatory affairs topics. Department intends to fill one vacancy and may choose to fill at any of the below job levels dependent on business needs and budget. 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. Expected Pay Range: $50,909 to $77,166 Regulatory Affairs Specialists, 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. Expected Pay Range: $61,599 to $93,370 Regulatory Affairs Specialists, 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. Expected Pay Range: $74,535 to $112,978
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, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Regulatory Affairs Specialists, III: Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. Regulatory Affairs Specialists, IV: Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience.
Preferences	Preferences Advanced degree (MS, PharmD, PhD, MD). Global regulatory experience. Deep understanding of ICH GCP, FDA, and international regulatory guidelines. Proven ability to lead regulatory strategy and execution for complex clinical programs Bachelor’s degree in life sciences, regulatory affairs, or related field. Minimum 10 years’ regulatory affairs experience within a regulatory agency (e.g., FDA), or in the pharmaceutical, biotechnology, or CRO industry. Demonstrated experience interacting directly with the FDA and/or other regulatory authorities. Strong knowledge of US regulatory requirements (e.g., IND, IDE, emergency IND, NDA, etc.). Excellent scientific writing and document review skills. Strong organizational skills with the ability to manage multiple projects and priorities. High attention to detail and commitment to quality. Applicants will be screened according to preferences.
Type	Benefited Staff
Special Instructions Summary
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: https://www.utah.edu/nondiscrimination/ Online reports may be submitted at oeo.utah.edu https://safety.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.

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
* Will you now or in the future require sponsorship for employment visa status (e.g., H-1B status)?
- Yes
- No
* Are you legally authorized to work in the United States?
- Yes
- No

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

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