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.
This position is posted at multiple job levels. Each level has distinct qualifications, responsibilities, which will be evaluated during the selection process. Final placement, including the associated pay rate, will be determined based on business needs and budget considerations.
Department Summary
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.
Responsibilities
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.
- Prepare and submit IRB applications, amendments, and reports to support study start-up and ongoing compliance.
- Track IRB submissions, complete required revisions, and ensure adherence to established timelines.
- Prepare and maintain study training logs and regulatory documentation (e.g., DOA logs).
- Manage and maintain regulatory binders/ISF and associated study documentation.
- Ensure all regulatory documents, certifications, and licenses are current and maintained.
- Monitor updates to University of Utah IRB policies and processes and apply changes to study activities.
- Communicate regulatory and IRB updates to study teams to ensure ongoing compliance.
- Review and maintain familiarity with active study protocols to support regulatory requirements.
- Collaborate with study teams and sponsors to finalize regulatory documents (e.g., ICFs).
- Ensure timely completion of regulatory submissions and revisions in accordance with study timelines.
- Assist in the development and maintenance of internal SOPs, as needed.
- Assist with additional regulatory or study-related tasks as needed to support compliance and operational objectives.
Regulatory Affairs Specialist (Life Sciences), I
Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree. Expected Pay Range: $46,584 to $57,976
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. Expected Pay Range: $51,242 to $69,629
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. Expected Pay Range: $62,004 to $84,252
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. Expected Pay Range: $68,204 to $92,678
