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

Job Description Summary We are seeking a highly motivated analytical R&D chemist to join our research and development team. We require 2 to 5 years’ experience and Post graduate chemistry/Analytical in developing and validating analytical methods for testing of API and release according to ICH and regulatory requirements. Having through knowledge of GMP operation and ability to work on Wet analysis and analytical instruments HPLC/GC/GCMS/IR/LCMS. Job Description To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab and maintain cleanliness of instruments and equipment’s. To support and perform analytical method Development for each project timely. To support and perform analytical validation/Method transfer for each project timely To support regulatory requirement as per committed timeline. To provide analytical support related to production for sorting out issues, yield improvement and further optimizing the process as per schedule. To Sample/analyze RM,KSM, in process, cleaning, intermediate, stability and API and report preparation To Analysis and documentation of Reference standard samples as per MTH To support and perform analytical method development/Validation for EI by ICPMS and,IC,GCMS LCMS timely. To ensure completion of documents & data integrity and regulatory environment To support for Calibration/Preventive maintenance of all analytical instruments Review of all executed analytical documents. Maintenance for HPLC /GC Columns. To perform Partial validation, Holding study, DMF queries and physiochemical studies Responsibility for QMS system like Change control, Deviation and CAPA and related to QMS.