Regulatory Submissions (Study Start Up) Coordinator
On-site
Core
Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics Committees; manage responses to queries and amendments; ensure compliance with regulations.
Role type
Regulatory Submissions Coordinator (Clinical Operations)
Builds
Regulatory submission packages for clinical trials
Domain
Clinical Research / Regulatory Affairs
Required skills
Regulatory documentation preparation, Ethics Committee submissions, Query response formulation, Regulatory guideline knowledge, Clinical Trial Management System (CTMS) maintenance, Essential document collection
Preferred skills
Life Sciences degree background, CRO/Pharma site experience, Independent work, Proactive approach, Microsoft Office proficiency
Technologies
Clinical Trial Management System, Microsoft Office
