Essential Functions:
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.
1. Prepare and submit IRB applications, amendments, and reports to support study start-up and ongoing compliance.
2. Track IRB submissions, complete required revisions, and ensure adherence to established timelines.
3. Prepare and maintain study training logs and regulatory documentation (e.g., DOA logs).
4. Manage and maintain regulatory binders/ISF and associated study documentation.
5. Ensure all regulatory documents, certifications, and licenses are current and maintained.
6. Monitor updates to University of Utah IRB policies and processes and apply changes to study activities.
7. Communicate regulatory and IRB updates to study teams to ensure ongoing compliance.
8. Review and maintain familiarity with active study protocols to support regulatory requirements.
9. Collaborate with study teams and sponsors to finalize regulatory documents (e.g., ICFs).
10. Ensure timely completion of regulatory submissions and revisions in accordance with study timelines.
11. Assist in the development and maintenance of internal SOPs, as needed.
12. Assist with additional regulatory or study-related tasks as needed to support compliance and operational objectives.
The following job levels and associated pay rates will be considered based on job placement. Final placement, including the corresponding pay rate, will be determined by the department in alignment with business needs and budget considerations.
Regulatory Affairs Specialist (Life Sciences), 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) with up to 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: PZ6891
Grade: P13
Expected Pay Range: $46,584 to $57,976
Regulatory Affairs Specialist (Life Sciences), 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: PZ6892
Grade: P14
Expected Pay Range: $51,242 to $69,629
Regulatory Affairs Specialist (Life Sciences), 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.
Job Code: PZ6893
Grade: P16
Expected Pay Range: $62,004 to $84,252
Regulatory Affairs Specialist (Life Sciences), 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.
Job Code: PZ6894
Grade: P17
Expected Pay Range: $68,204 to $92,678
Disclaimer:
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
