Regulatory Specialist II
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Job Location:
Aurora, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
University of Colorado Denver (Anschutz)
Job Description:
Provide regulatory support and expertise throughout the lifecycle of projects that fall under the IND/IDE Offices oversight primarily in the area of single patient compassionate use requests. Responsible for submission of single patient Compassionate Use Requests to various branches of FDA and to internal entities per institutional policies. Support the Senior Regulatory Specialist as needed by ensuring all required documentation and sections/modules for submissions to FDA are complete and formatted per FDA requirements and by identifying missing or incomplete documentation and tracking and managing requests for outstanding documentation. Meet regularly with the PI and study team to review content and progress of application packages to various branches of FDA. Manage the submission of expedited and routine reports to FDA. Maintain version control for documentation throughout the IND/IDEs life cycle. Identify and elevate barriers delaying any FDA submissions and assists with identifying solutions. Participate in process improvement initiatives. Assist in developing and providing Standard Operating Procedures educational resources and training for IND/IDE Office team members and investigators and their research teams. Work directly with the Offices Medical Directors Principal Investigators (PIs) and collaborates with institutional partners including the Clinical Research Administrative Office the IRB and clinical teams. Position is 100% remote reporting to University of Colorado Denver Anschutz campus in Aurora CO.
Job Requirements:
Salary: at least $66664.00 per year.
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Required Experience:
IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
The University of Colorado (CU) is a premier public research university with four campuses: Boulder, Colorado Springs, Denver, and the Anschutz Medical Campus.
