Manager 2 - Labeling - US Market

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Title: Manager 2 - Labeling - US MarketDate: Jul 14, 2025Location: Gurgaon - R&DCompany: Sun Pharmaceutical Industries Ltd

Original Application submission

  • Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve‐outs based on patents and exclusivity claims

Labeling Query responses/ REMS and Patent Amendments/ PNP Requests

  • Thorough review/interpretation of FDA comments.
  • Review of revised labeling and response.
  • Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments
  • Review of patent amendment & proprietary name review request
  • Submission of Final Approval Requested

Life Cycle Management

  • Track RLD labeling changes
  • Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA
  • Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS)
  • Timely submission of REMS
  • Review of revised artworks
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