Regulatory Specialist II

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Closing Date:

09/02/2026

Type of Position:

Professional Staff - Fiscal Affairs

Job Type:

Regular

Work Shift:

Day Shift (United States of America)

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 the Apply 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 | Regulatory Affairs Unit

Department's Website:

Summary 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.
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.
All UAMS employees will treat others with Dignity and Respect. We communicate and share complete and unbiased information, assuring our colleagues receive timely, complete, and accurate information in order make informed decisions. We participate in institutional initiatives and encourage the participation of others. We collaborate in policy and program development, implementation, and evaluation using best practices in delivering quality service. All duties will be performed in accordance with the UAMS Core Concepts of Patient and Family Centered Care set forth by UAMS. These core concepts allow for an approach to health care that shapes policies, programs, facility design and staff day-to-day interactions. It leads to better health outcomes and wiser allocation of resources, and greater patient and family satisfaction. The core concepts of patient and family centered care consist of Dignity & Respect, Information Sharing, Participation, and Collaboration.

Qualifications:

• Level II: PhD (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus experience in clinical research related to FDA Regulatory Affairs (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.) OR
• Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 3 years of experience in clinical research related to FDA Regulatory Affairs, OR
• High School Diploma plus 7 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, Resume

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:

Sitting

Frequent Physical Activity:

Hearing

Occasional Physical Activity:

Standing, Talking

Benefits Eligible:

Yes