The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions.
The RPA properly manages personal timelines and workload distribution between short term and long term deliverables such that all project deadlines are respected.

This role will be perfect for you if:
You want to have an experience in regulatory and scientific affairs;
You want to work in a cooperative workplace;
You want to have an impact in a rapid-growing company

RESPONSIBILITIES

More specifically, the Regulatory Project Assistant:
Uploads and maintains documentation in CTIS EMA portal for initial applications, amendments, and notifications. Maintains submission components in accordance with requirements and tracks timelines
Files CTIS documentation to the eTMF




Prepares redaction of Part II and selected Part I documents for CTIS submission.
Prepares IRB-related documentation for eTMF filing (eg, approval letters, communications, and approved documents from IRB portals)
Supports user requests and site creation for IRB portals
Supports the reconciliation of eTMF user access lists against employee list on a periodic basis.
Prepares project documentation for ethics and regulatory submissions
Prepares, maintains, and updates regulatory trackers for assigned studies
Verifies, reconciles, and tracks vendor invoices for ethics services
Compiles and formats Clinical Study Reports (CSRs) and appendices as per requirements for electronic submissions (eg, PDF, bookmarks, hyperlinks, eCTD).
Assists with initiating, maintaining, and reviewing the eTMF
Assists with project tracking activities and status reports preparation
Participates in various administrative tasks, as required, to accompli

📌 Regulatory Project Assistant India New Delhi
🏢 Indero
📍 New Delhi