job title: Executive - Regulatory Affairs (sun pharma)

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.