**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 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.