Company: Sun Pharmaceutical Inds Ltd, Baroda
Opening: Regulatory Affairs - US group (Labeling)
Experience: 3 - 5 years
Job Description:
1. Original Application submission
ü 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
2. Labeling Query responses/ REMS and Patent Amendments/ PNP Requests
ü Thorough review/interpretation of FDA comments.
ü Preparation / Review of revised labeling and response.
ü Tracking/ Review for Completeness/ Timely Submission of Amendments
ü Preparation / Review of patent amendment & proprietary name review request
ü Submission of Final Approval Requested
3. Life Cycle Management
ü Track RLD labeling changes
ü Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA
ü Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS)
ü Timely submission of REMS
ü Review of revised artworks
ü Databases/ artwork repository maintenance
Send your resume to : Rosemary.varghese@sunpharma.com
Freshers need not apply
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