University of Arkansas for Medical Sciences

Regulatory Specialist III

University of Arkansas for Medical Sciences  •  United States (Onsite)  •  20 hours ago
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Job Description

Current University of Arkansas System employees, including student employees and graduate assistants, need to log in to Workday via MyApps.Microsoft.com, then access Find Jobs from the Workday search bar to view and apply for open positions. Students at University of Arkansas System will also view open positions and apply within Workday by searching for “Find Jobs for Students”.

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Closing Date:

08/31/2026


Type of Position:

Professional Staff - Fiscal Affairs


Job Type:

Regular


Work Shift:

Sponsorship Available:

No


Institution Name:

University of Arkansas for Medical Sciences


The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.

UAMS offers amazing benefits and perks ( available for benefits eligible positions only):

  • Health: Medical, Dental and Vision plans available for qualifying staff and family
  • Holiday, Vacation and Sick Leave
  • Education discount for staff and dependents (undergraduate only)
  • Retirement: Up to 10% matched contribution from UAMS
  • Basic Life Insurance up to $50,000
  • Career Training and Educational Opportunities
  • Merchant Discounts
  • Concierge prescription delivery on the main campus when using UAMS pharmacy

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click theApply link/button.

The University of Arkansas is an equal opportunity institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of any category or status protected by law, including age, race, color, national origin, disability, religion, protected veteran status, military service, genetic information, sex, sexual preference, or pregnancy. Questions or concerns about the application of Title IX, which prohibits discrimination on the basis of sex, may be sent to the University’s Title IX Coordinator and to the U.S. Department of Education Office for Civil Rights.

Persons must have proof of legal authority to work in the United States on the first day of employment.

All application information is subject to public disclosure under the Arkansas Freedom of Information Act.

For general application assistance or if you have questions about a job posting, please contact Human Resources at askrecruitment@uams.edu


Department:

RESH | Quality Assurance Unit


Department's Website:


of Job Duties:

The Research Regulatory Specialist (RRS) is expected to have excellent problem-solving, critical thinking, negotiation, and teamwork skills as well as excellent written and verbal communication skills. A successful candidate should be organized, able to multi-task, maintain a positive, helpful attitude, and take direction from Manager of Regulatory Affairs. This position supports faculty who submit applications to FDA to obtain permission to study investigational drugs, biologics, and medical devices.

The primary tasks include preparation, submission, and maintenance of regulatory documents required for UAMS-sponsored IND and/or IDE applications and files. Applicants will be expected to assist with review of clinical research protocols, assuring that content meets the requirements of the U.S. Food and Drug Administration (FDA) and the UAMS Institutional Review Board. This position will require applicants to coordinate activities of investigators, other Office of Research Regulatory Affairs (ORRA) staff, and ancillary staff to achieve rapid and accurate project completion, meet deadlines and deliver detailed written reports as necessary.

In addition to initial FDA submissions, the Research Regulatory Specialist must understand pertinent regulations, manage adverse event reporting, handle annual reports, coordinate communication with FDA, and apply pertinent federal regulations to individual research proposals. The successful applicant will be expected to prepare and provide presentations; assist in the development of forms, templates, and project-specific documents; assist in the development of policies and procedures pertaining to regulatory matters and internal procedures.


Qualifications:

  • Level III: PhD (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.), OR
  • a bachelor's degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 5 years of experience in clinical research related to FDA Regulatory Affairs, OR
  • High School Diploma plus 9 years of experience in clinical research related to FDA Regulatory Affairs OR equivalent combination of education and experience.


Additional Information:


Salary Information:

Commensurate with education and experience")


Required Documents to Apply:

Curriculum Vitae


Optional Documents:


Special Instructions to Applicants:


Recruitment Contact Information:

Please contact askrecruitment@uams.edu for any recruiting related questions.


All application materials must be uploaded to the University of Arkansas System Career Site https://uasys.wd5.myworkdayjobs.com/UASYS

Please do not send to listed recruitment contact.


Pre-employment Screening Requirements:

No Background Check Required


This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity. The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law.


Constant Physical Activity:

Walking


Frequent Physical Activity:

Talking


Occasional Physical Activity:

Hearing, Sitting, Standing


Benefits Eligible:

Yes

University of Arkansas for Medical Sciences

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