Regulatory Operations Assistant

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Operations Assistant based in United States.

This remote role supports the regulatory administration of investigational drug studies within a specialized oncology clinical research environment.
You will help maintain accurate, complete, and audit-ready Investigator Site Files and ensure essential study documentation is properly managed throughout the study lifecycle.
The position involves close coordination with investigators, study teams, monitors, institutional review boards, sponsors, and contract research organizations.
You will manage regulatory submissions, study logs, training records, safety reports, investigator credentials, and other critical documentation.
Your attention to detail and ability to keep information organized will directly support regulatory compliance and smooth clinical trial operations.
This opportunity is well suited to a highly organized professional who can work independently while maintaining consistent communication with multiple stakeholders.
You will join a collaborative environment focused on advancing clinical research and helping bring promising treatments to patients.