Regulatory Specialist III

University of Arkansas System

Research Regulatory Specialist supporting faculty in FDA applications for investigational drugs and medical devices. Managing regulatory documents and ensuring compliance with FDA and UAMS standards.

Posted 7/20/2026full-timeLittle Rock • 🇺🇸 United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in FDA Regulatory Affairs, including preparation and submission of IND and IDE applications, while effectively coordinating communication and activities among research teams. Proficient in developing regulatory documents and ensuring compliance with federal regulations.

Highest-signal resume keywords

FDA Regulatory AffairsIND/IDE Application PreparationClinical Research Protocol ReviewAdverse Event ReportingRegulatory Document Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationClinical ResearchFDA SubmissionRegulatory ComplianceProtocol Review

Soft Skills

Problem-SolvingCritical ThinkingNegotiationTeamworkCommunication

Industry Keywords

U.S. Food and Drug AdministrationInvestigational DrugsBiologicsMedical DevicesInstitutional Review Board

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

Level III: PhD (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent)
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.

Benefits

Comp & perks

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