job title:senior associate - regulatory affairs(endo international)

Job Description Summary

The Regulatory Affairs Senior Associate is responsible for the preparation, compilation, evaluation and submission of ANDAs & Amendments to USFDA and handling deficiencies with timely submission of responses to agency.

Job 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