Sr. Associate

2 weeks ago

Digha, India Endo International Full time

Description

Coordinate with cross functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required and evaluation of documents in-line with the current regulatory requirements Review of Product Development Report, Executed and Intended Batch Records, Specifications, Analytical Procedures, Method Validation Protocols and Reports & Certificate of Analysis of API/Excipients/In-Process/Finished products/Packaging materials, stability protocols and reports. Review of vendor documents of API, Excipients and Packing materials Review of documents for adequacy (w.r.t content, requirements, legibility, PDF requirements, etc.) Preparation, review and compilation of ANDAs, Amendments and Supplements in eCTD format. Coordinate with Regulatory Operation team member for uploading the submission in e CTD software Review of exported submission shared by Regulatory Operation team for submission. Monitor the FDA website for any updation.

Education & Experience :- Master of Pharmacy in Dept. of Pharmaceutics

Total experience of 3-5 Years in Regulatory Affairs 

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