Regulatory Project Assistant-India
Core
Provides project administrative support to regulatory affairs and eTMF operations teams, ensuring timely entry of information for EU submissions via the Clinical Trial Information System (CTIS).
Role type
Administrative Project Assistant (Regulatory)
Builds
Regulatory submission components, ethics documentation, and project trackers for EU clinical trials. (via careerplan.io/jobs/15-003-6C-271-regulatory-project-assistant-india-at-indero)
Domain
Clinical Research / Regulatory Affairs / eTMF Operations
Required skills
Regulatory submission management, eTMF operations, CTIS portal navigation, document redaction, project tracking, vendor invoice reconciliation, Clinical Study Report (CSR) formatting, Microsoft Office suite, PDF editing
Preferred skills
Biotechnology/pharmaceutical/CRO industry experience, knowledge of EU CTR regulation
Technologies
CTIS, eTMF, Microsoft Office, PDF editors
Responsibilities
Uploads and maintains documentation in CTIS EMA portal; Files CTIS documentation to eTMF; Prepares redaction of Part II and selected Part I documents; Prepares IRB-related documentation for eTMF filing; Supports user requests and site creation for IRB portals; Reconciles eTMF user access lists; Prepares project documentation for ethics and regulatory submissions; Prepares and updates regulatory trackers; Verifies and tracks vendor invoices for ethics services; Compiles and formats Clinical Study Reports (CSRs) and appendices; Assists with initiating, maintaining, and reviewing the eTMF; Assists with project tracking activities and status reports preparation.
Seniority
Entry-level / Administrative Support