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 of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students._ _Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. 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._ _The University of Utah is an Affirmative Action/Equal Opportunity employer and 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 Affirmative Action:_ _Director/ Title IX Coordinator_ _Office of Equal Opportunity and Affirmative Action ( OEO /AA)_ _383 University Street, Level 1 OEO Suite_ _Salt Lake City, UT 84112_ _801-581-8365_ _oeo@utah.edu_ _Online reports may be submitted at_ **oeo.utah.edu** **_For more information:_** **https://www.utah.edu/nondiscrimination/** **_To inquire about this posting, email:_** **employment@utah.edu** **_or call 801-581-2300._** _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._ _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._