- Professional
- Optionales Büro in Digha
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
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