Regulatory Affairs Associate - Full Time - Germantown, TN
Core
Coordinate regulatory submissions and approvals for multiple clinical research studies, ensuring compliance with federal regulations.
Role type
Associate-level Regulatory Affairs Specialist (Clinical Research)
Builds
Regulatory documentation and submissions for clinical trials
Domain
Healthcare / Clinical Research
Required skills
Regulatory submission coordination, IRB approval management, safety report processing, federal regulations knowledge, GCP familiarity, document compilation, site change management
Preferred skills
Associate's or Bachelor's degree, Research certification
Technologies
Word, Excel, Adobe Acrobat
Responsibilities
Coordinate initial and ongoing IRB approvals, maintain regulatory documentation for multiple studies, collect and maintain site-specific regulatory documents, prepare and submit study documents to IRB/Sponsors/FDA, process safety reports, manage site changes and regulatory updates, assist with report compilation and quality control
Seniority
Associate, hands-on IC