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Sun Pharma Job Vacancy For BPharm/ MPharm/ MSc



Job Availables, Sun Pharma Job Vacancy For BPharm/ MPharm/ MSc
Sun Pharma Job Vacancy For BPharm/ MPharm/ MSc



Opening in Regulatory Affairs

Vacancy Details:

Qualification: B.Pharm/M.Pharm/M,Sc

Experience: 1-5 yrs 

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 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


3. 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 hr.tandalja@sunpharma.com

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