Sun Pharma Hiring For Regulatory Affairs - US

Sun Pharma Hiring For Regulatory Affairs - US

Sun Pharma Job Vacancy Details: 

Sun Pharmaceutical Inds Ltd, Baroda Opening in Regulatory Affairs - US group (Labeling)

Experience : 3 - 5 years



Job Description:
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/ REMS and Patent Amendments/ PNP Requests Thorough review/ interpretation of FDA comments.

3 Preparation / Review of revised labeling and response.

4 Tracking/ Review for Completeness/ Timely Submission of Amendments

5 Preparation / Review of patent amendment & proprietary name review request

6 Submission of Final Approval Requested

7 Life Cycle Management

8 Track RLD labeling changes

9 Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA

10 Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS)

11 Timely submission of REMS

12 Review of revised artworks

13 Databases/ artwork repository maintenance

How To  Apply For Sun Pharma Job 

Send your resume to : Rosemary.varghese@sunpharma.com
Freshers need not apply