About the Company
About the Job
Sun Pharma - Baroda
Opening in Regulatory Affairs
Qualification : B.Pharm/M.Pharm/M,Sc
Experience : 1-5 yrs in:
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 and Patent Amendments
Thorough review/interpretation of FDA comments.
Review of revised labeling and response.
Tracking/ Review for Completeness/ Timely Submission
Review of patent amendment
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)
Review of revised artworks
Send in your resume to [email protected]
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Experience: Freshers
Qualification: M Pharm (Chemistry)
send your resume to: [email protected]
Joining: Immediately
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