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Sun Pharma – Openings in Regulatory Affairs

Sun Pharma – Openings in Regulatory Affairs

Sun Pharmaceutical Industries Limited is the largest specialty generic pharmaceutical company in the world. We provide high quality, affordable medicine trusted by healthcare professionals and patients in over 150 countries. It is also India’s largest, most trusted and most valuable pharmaceutical company by market capitalization. To keep pace with our growth plan we require young and energetic professionals of our plant at Baroda.

Hiring alert
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

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

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