Regulatory Affairs Associate

Job Description

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