Executive - Regulatory Affairs

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.