Regulatory Specialist II

University of Arkansas System•Little Rock, AR

23h•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. 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 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 [email protected].

Requirements

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.)
Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 3 years of experience in clinical research related to FDA Regulatory Affairs
High School Diploma plus 7 years of experience in clinical research related to FDA Regulatory Affairs
Equivalent combination of education and experience.
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.
Proof of legal authority to work in the United States on the first day of employment.

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.
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.