Regulatory Specialist

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).
• Auxiliary in the development and maintenance of internal SOPs, as needed.
• Auxiliary in additional regulatory or study-related tasks as needed to support compliance and operational objectives.

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).
• The 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.
• Experience with University of Utah IRB.
• Clinical research regulatory experience.
• CITI Training (or to be completed within 1 month of hire).