Sun Pharma Hiring For Regulatory Affairs - US
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Sun Pharma Hiring For Regulatory Affairs - US |
Sun Pharma Job Vacancy Details:
Sun Pharmaceutical Inds Ltd, Baroda Opening in Regulatory Affairs - US group (Labeling)
Experience : 3 - 5 years
Job Description:
1. 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
Job Description:
1. 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
2. Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/ interpretation of FDA comments.
3 Preparation / Review of revised labeling and response.
4 Tracking/ Review for Completeness/ Timely Submission of Amendments
5 Preparation / Review of patent amendment & proprietary name review request
6 Submission of Final Approval Requested
7 Life Cycle Management
8 Track RLD labeling changes
9 Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA
10 Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS)
11 Timely submission of REMS
12 Review of revised artworks
13 Databases/ artwork repository maintenance
How To Apply For Sun Pharma Job
Send your resume to : Rosemary.varghese@sunpharma.comFreshers need not apply
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