Experienced Regulatory Submissions Coordinator
Core
Provide day-to-day support for Regulatory Submissions Coordinators, assemble regulatory start-up submissions, and prepare clinical trial applications for research sites.
Role type
Support-level Regulatory Submissions Coordinator
Builds
Regulatory documentation and clinical trial applications
Domain
Clinical research / Biopharmaceuticals
Required skills
Regulatory documentation preparation, Clinical trial application filing, Database management, Site communication, Timeline management, Compliance verification
Preferred skills
Life Sciences background, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Collect, review, organize, and assemble regulatory start-up submissions; Prepare, review, and file clinical trial applications; Communicate with research sites to collect essential documents; Maintain timelines for study start-up; Ensure submissions comply with applicable regulations.
Seniority
Junior, Support IC
