Senior Executive - Regulatory Affairs

About the role

Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline. Coordination with inter departments (QA, QC, R&D, MSAT etc.) for source documents required for various regulatory submissions.

What you'll do

• Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe

What you need

• Regulatory affairs
• Documentation
• SAP
• Any graduate