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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