Sr. Associate - Regulatory Affairs (CMC)

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