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