Sun Pharma – Hiring for Regulatory Affairs

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 4.5 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.

Vacancy Details

Department: Regulatory Affairs
Qualification : B.Pharm/M.Pharm/M.Sc
Experience : 1-5 yrs
Location: Baroda

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 your resume to hr.tandalja@sunpharma.com

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