Regulatory Submission Specialist - Chandigarh, India

Job Overview

We are seeking a highly skilled and detail-oriented Submission Expert specializing in Individual Case Safety Reports (ICSR) and aggregate report submissions to join our Pharmacovigilance team. This role is critical in ensuring the timely and accurate submission of ICSRs and aggregate reports to regulatory authorities in compliance with global pharmacovigilance regulations and guidelines.

Functional Responsibilities:
- Manage timely submission of global ICSRs to health authorities, license partners, and CROs.
- Prepare local paper submissions to the US FDA, following client-specific processes.
- Proficient in ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) for approved and investigational drugs, biologic, and medical devices.
- Support safety reporting for aggregate reports/periodic safety reports and related activities.
- Perform and oversee aggregate report submissions to regulatory authorities (RAs), ethics committees (ECs), institutional review boards (IRBs), and investigators.




- Track and archive aggregate report submissions and correspondence.
- Support EudraVigilance registration and account maintenance, as well as registration to other regulatory portals for submissions.
- Generate, review, and transmit reports to global health authorities (e.g., FDA, EMA, MHRA, Health Canada).
- Stays updated on regulatory requirements through regulatory intelligence to ensure compliance with submission rules across global health authorities
- Maintaining the submission requirements tracker with country-level safety reporting requirements.
- Ensure timely report submissions to global partners in line with PVAs.
- Participate in gateway-to-gateway ICSR submission testing with health authorities and partners.
- Prepare ICSR submission packages per regulatory requirements.
- Monitor global submission mailboxes to address high-priority queries from authorities and partners.
- Manage daily sub

📌 Regulatory Submission Specialist (Chandigarh)
🏢 Ydts Global
📍 Chandigarh