Regulatory Project Assistant-India
Core
Provides project administrative support to regulatory affairs and eTMF operations teams, ensuring timely and complete data entry in the EU Clinical Trial Information System (CTIS).
Role type
Regulatory Project Assistant
Builds
Regulatory submission components and eTMF documentation for EU clinical trials (via careerplan.io/jobs/15-003-6C-271-regulatory-project-assistant-india)
Domain
Biotechnology / Pharmaceutical / Clinical Research
Required skills
Regulatory affairs knowledge, eTMF operations, CTIS portal management, document redaction, IRB documentation handling, vendor invoice reconciliation, Clinical Study Report (CSR) compilation, Microsoft Office suite, PDF editing
Preferred skills
Biotechnology/pharmaceutical/CRO industry experience, EU CTR regulation knowledge
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
Individual Contributor