Title: Executive - Regulatory Affairs
Date:
Jul 4, 2025
Location:
Tandalja - R&D
Company:
Sun Pharmaceutical Industries Ltd
- Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.
- Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations.
- Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates.
- Coordination of labeling related activities with cross functional teams for timely launch of products.
- Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares.
- Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development.
- Evaluation and coordinating with departments for REMS requirement for applications.