Regulatory Affairs Associate

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports. - Reviewing analytical method validation protocols and reports. - Reviewing raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures. - Reviewing batch records. - Reviewing Process Validation Protocols, hold time study protocols, and reports. - Reviewing Product Development Reports. - Reviewing executed documents including executed BMR, Certificate of Analysis to ensure compliance with regulatory requirements.,