Title:  Manager 2 - Labeling - US Market

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