Executive - Regulatory Affairs

SUN PHARMA


Date: 9 hours ago
City: Vadodara, Gujarat
Contract type: Full time
  • 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.

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