Regulatory Specialist I

Overview: The Regulatory Affairs Specialist (RAS) 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 Regulatory Affairs Manager (RAM). 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/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 (IRB). 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 RAS 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.
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 the health, health care, and well-being of Arkansans.
UAMS offers amazing benefits and perks:

• Health: Medical, Dental and Vision plans available for 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

Salary: offered commensurate with experienceResponsibilities:Responsibilities for the Regulatory Affairs Specialist I:Level I:The Regulatory Affairs Specialist (RAS I) will be trained to apply relevant parts of the Code of Federal Regulations (21 CFR 312, 21 CFR 812, etc.) to prepare documents for initial FDA submissions as well as subsequent filings including but not limited to modified protocols, consent forms, IND safety reports, serious adverse events (SAEs), unanticipated device adverse effects (UADE), and annual progress reports (APRs). Primary job functions do not typically require exercising independent judgment (as proficiency increases, a more independent approach is determined).

• Work under immediate supervision of the Regulatory Affairs Manager (RAM) or RAS III.
• Rely on instructions and pre-established guidelines to perform the functions of the job.
• Manage 3-10 IND/IDE projects, including the preparation, submission, and maintenance of regulatory.
• Work effectively with investigators to ensure that appropriate data is collected/submitted in accordance with the FDA regulations.
• Interact continuously with other ORRA personnel and research administration.
• Interact with investigators, research coordinators, and administrators to communicate regulatory requirements effectively.
• Develop and maintain relationships with internal and external customers.
• Responsible for quality work products.
• Attend office meetings, project team meetings and UAMS clinical research events.
• Participate on project development team as assigned.
• Assist in the development of internal forms and templates.
• Assist in the development of presentations to research personnel.
• Accept other assignments as deemed necessary by the RAM or ORRA Director
• Prepare communications for investigators/study teams with RAM and/or RAS III.
• Interact in a limited capacity with external regulatory agencies.

Qualifications:Minimum Qualifications:
Level I:

• Bachelor's Degree Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent plus 1 years of experience in clinical research and/or FDA Regulatory Affairs (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.) related OR High School plus 5 years of experience in clinical research and/or FDA Regulatory Affairs OR equivalent combination of education and experience.
• Must obtain CRS certification within 1 year of hire. CRS certification must be maintained.
• Membership in RAPS within 6 months of hire date.

Special knowledge, abilities and skills:

• Ability to work consistently and effectively as part of a high performance work team.
• Advanced interpersonal, verbal, written, project management and organizational skills
• Ability to effectively devote keen and acute attention to detail
• Advanced knowledge of medical terminology
• Advanced knowledge of FDA Drug/Device Regulations, specifically 21 CFR 312 and §812 and Guidances.
• Working knowledge of ICH E6, 21 CFR 11, §50, §54, §56
• Advanced knowledge of Microsoft Word, Excel, PowerPoint, and Outlook
• Working knowledge of Microsoft SharePoint, Access, Teams and Skype for Business

Preferred Qualifications:
Level I:

• Masters in Regulatory Sciences, Pharmaceutical Sciences or Life/Natural/Clinical sciences or equivalent
• 6+ months experience as ClinicalTrials.gov Administrator role and or 2+ years specific experience in FDA Regulatory Affairs (Drugs, Biologics and/or Medical Devices)
• CCRP and/or RAC certified or willing to obtain CCRP or RAC certification within 2 years of hire date.

Special knowledge, abilities and skills:
Level I:

• cGMP for drugs/biologics/devices
• Working knowledge of 21 CFR 58, §210, §211, §314, §600, §814, §820, §1270, §1271, 42 CFR 11 & ClinicalTrials.gov
• Working knowledge of ISO 13485, 14971 & 14155
• Advanced Microsoft Access experience preferred

UAMS is an Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence. If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (501) 686-6432 and let us know the nature of your request. We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA).Physical Requirements: Stand: Occasionally
Sit: Frequently
Walk: Occasionally
Bend, crawl, crouch, kneel, stoop, or reach overhead: Occasionally
Lift, push, pull, carry weight: 11 - 25 lbs
Use hands to touch, handle, or feel: Occasionally
Talk: Frequently
Hear: Frequently
Taste or smell: Never
Read, concentrate, think analytically: Continuously
Physical Environment: Inside Office Environment
Noise Level: Quiet
Visual Requirements: Depth perception, Far visual acuity, Near visual acuity
Hazards: None