Associate, Regulatory Affairs- Labeling

Sun Pharmaceutical Industries Ltd•Princeton, NJ

4d•$94,500 - $105,000

About The Position

This role is responsible for the preparation of various regulatory Labeling submissions and as well as review of labeling documents for submission.

Bachelor's degree, in scientific field.
1-3 years of regulatory experience in the generic pharmaceutical industry.
Advanced computer skills required.
Solid writing and communication skills and the ability to work independently in preparation of regulatory documents and correspondence.

Travel between Princeton and Hawthorne location may be required, as defined by business needs

Preparation and timely completion of labeling for ANDA dossiers for Labeling submissions and prepare and review response to labeling deficiencies to secure approval.
Prepare and submit updated labeling to the FDA
Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS) for commercial products.
Prepare Drug Listings for newly approved labels and private label products and resolve returned listing problems.
Ensure to revise SPL for each revision to (Rx and OTC)
Routine Monitoring of FDA web sites for revisions to labeling for RLD Updates corresponding to our ANDAs.
Track and prepare labeling summary for incorporation into annual reports.
Maintain documents on approved and newly filed products and also Life Cycle Management.
Assist with the completion of information for New Product Information (NPI)
To assist with preparation of Master Text for OTC products before launch and work on timely revisions to ensure they are in line with the National Brand Equivalent. Ensure proper reposition of Master Text for all OTC products.
Other duties as assigned