Sun Pharma – Openings in Regulatory Affairs B.Pharm/M.Pharm/M.Sc
Sun Pharma – Openings in Regulatory Affairs B.Pharm/M.Pharm/M.Sc
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
- 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 hr.tandalja@sunpharma.com