This role is responsible for the preparation of various regulatory Labeling submissions and as well as review of labeling documents for submission.
Duties and responsibilities
- Review 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 in eCTD / Amplexor to the FDA
- Review labeling revisions for Taro and private label products and Contract Manufacturers.
- Initiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS).
- Facilitate timely launches and ongoing supply to the market with the creation of HDA, SDS, Checklist, etc.
- Prepare Drug Listings for newly approved TARO labels and private label products and resolve returned listing problems.
- Reserve NDC numbers for Taro and customer labeling.
- Ensure to revise SPL for each revision to artwork (both TARO and Customer artworks, Rx and OTC)
- Monitor FDA web sites for revisions to labeling for RLD of Taro products.
- Assist with customs release inquiries.
- Track and advice of all labeling revisions for incorporation into annual reports.
- Respond to requests for information regarding marketed prescription and OTC products.
- Maintain documents on approved and newly filed products.
- Electronically search for new regulatory guidelines and regulations. Perform routine monitoring of Federal Register.
- Assist with review, approval and submission of Promotional Materials for Taro Products.
- Assist with projects such as FDA inspection, teleconferences arranging webinars, etc.
- Collect information to assist in compiling departmental budget.
- Assist with the completion of information for New Product Information (NPI)
- Assist with compilation of date for Annual Blanket No Change Certification Submission to FDA
- To prepare 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.
- Assist with the approval of Final Formula Approval Form shared from each site.
- To work with custom brokers to provide information on FDA Product Codes and HTS codes.
Qualifications
- Bachelor's degree, in scientific field.
- 3-5 years of regulatory experience in the generic pharmaceutical industry.
- Advanced computer skills required.
- Solid review, writing and communication skills and the ability to work independently in preparation of regulatory documents and correspondence.
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