Job Description

Summary
The Associate, Regulatory Affairs is responsible for supporting the regulatory efforts pertaining to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and all related regulatory compliance issues to support the company's internal and external approved product portfolio.
Compilation and submission of Post Approval Supplement viz. PAS, CBE-0, CBE-30.*
Preparation, Review and Submission of Amendments and supplements for the assigned products*
Preparation, Review and Submission of response to the Agency's queries for the assigned products*
Compilation and submission of Global Annual Report.*
Review of stability protocols and reports.*
Review of analytical method validation protocols and reports.*
Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.*
Review of batch records.*
Review of Process Validation Protocol, hold time study protocols and Repots*
Review of Product Development Report*
Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement*