Regulatory Specialist II

University of Colorado•Aurora, CO

1d•Remote

About The Position

Provide regulatory support and expertise throughout the lifecycle of projects that fall under the IND/IDE Office’s 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/IDE’s 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 Office’s Medical Directors, Principal Investigators (PIs) and collaborates with institutional partners including the Clinical Research Administrative Office, the IRB, and clinical teams. Position is 100%25 remote, reporting to University of Colorado Denver – Anschutz campus in Aurora, CO.

Requirements

Requires a Bachelor’s or Master’s degree in Public Health, Regulatory Affairs, Public Administration, Social/Behavioral Sciences, Healthcare, Business Administration, or related.
Requires two (2) years of professional-level clinical trial experience as a coordinator, regulatory staff, or other support position with a Bachelor’s degree OR 0 years’ experience required with a Master’s degree.
Must have experience in each of the following skills: Federal regulations and process for submitting INDs and IDEs to the FDA; Clinical trial regulatory work including submissions to institutional regulatory entities and external entities; Critically assessing a program solicitation; Project management; Maintaining and tracking regulatory data; Electronic Trial Master File systems and processes; Quality checks on published regulatory documentation; Content Verification processes; and SOP and work instruction development.

Responsibilities

Provide regulatory support and expertise throughout the lifecycle of projects that fall under the IND/IDE Office’s 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/IDE’s 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 Office’s Medical Directors, Principal Investigators (PIs) and collaborates with institutional partners including the Clinical Research Administrative Office, the IRB, and clinical teams.