Regulatory Specialist III
On-siteLittle Rock, Arkansas, United States
Little Rock, Arkansas, United StatesOn-siteFull TimeEnterprise
Full TimeEnterprise
Job Summary
Prepare, submit, and maintain regulatory documents for UAMS-sponsored IND and IDE applications to the FDA. Review clinical research protocols to ensure compliance with FDA and Institutional Review Board requirements. Coordinate activities with investigators, staff, and ancillary personnel to meet project deadlines and deliver detailed reports. Manage adverse event reporting, handle annual reports, and communicate with the FDA. Develop forms, templates, and policies pertaining to regulatory matters and internal procedures. Present findings and apply pertinent federal regulations to individual research proposals.
Required Qualifications
- PhD (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent)
- 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
- excellent problem-solving skills
- critical thinking skills
- negotiation skills
- teamwork skills
- excellent written and verbal communication skills
- ability to be organized
- ability to multi-task
- positive, helpful attitude
- ability to take direction from Manager of Regulatory Affairs
- understanding of pertinent regulations
- ability to coordinate activities of investigators, other Office of Research Regulatory Affairs (ORRA) staff, and ancillary staff
- ability to meet deadlines
- ability to deliver detailed written reports
- ability to prepare and provide presentations
- ability to assist in the development of forms, templates, and project-specific documents
- ability to assist in the development of policies and procedures pertaining to regulatory matters and internal procedures
- ability to manage adverse event reporting
- ability to handle annual reports
- ability to coordinate communication with FDA
- ability to apply pertinent federal regulations to individual research proposals
- knowledge of IND/IDE, BLA/NDA/ANDA, PMA, 510(k)
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