Regulatory Specialist III

University of Arkansas System•Little Rock, AR

6d•Onsite

About The Position

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. 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

PhD (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.)
Bachelor's degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 5 years of experience in clinical research related to FDA Regulatory Affairs
High School Diploma plus 9 years of experience in clinical research related to FDA Regulatory Affairs
Equivalent combination of education and experience.
Proof of legal authority to work in the United States on the first day of employment.
Excellent problem-solving, critical thinking, negotiation, and teamwork skills.
Excellent written and verbal communication skills.
Organized, able to multi-task, maintain a positive, helpful attitude, and take direction from Manager of Regulatory Affairs.

Responsibilities

Preparation, submission, and maintenance of regulatory documents required for UAMS-sponsored IND and/or IDE applications and files.
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.
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.
Understand pertinent regulations, manage adverse event reporting, handle annual reports, coordinate communication with FDA, and apply pertinent federal regulations to individual research proposals.
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.