
Regulatory Affairs Associate
3 hours ago
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.
Job Description
- _ 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_
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