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sun pharma industries
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Manager 2 - Labeling - US Market

Manager 2 - Labeling - US Market

sun pharma industries

10 - 17 years

|

11 - 12 Lacs

Posted:1 day ago| Platform:

Apply

Skills Required

contract management usfda iso correspondence administration anda nda packaging tracking ich ra ctd contract drafting drafting safety quality assurance contract review claims regulatory affairs drug regulatory affairs dmf formulation development ind

Work Mode

Work from Office

Job Type

Full Time

Job Description

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/ REMS and Patent Amendments/ PNP Requests

Thorough review/interpretation of FDA comments.
Review of revised labeling and response.
Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments
Review of patent amendment & proprietary name review request
Submission of Final Approval Requested

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)
Timely submission of REMS
Review of revised artworks

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