An established, self-motivated & result-oriented regulatory professional with more than a oneand half decade long broad & diversified experience in the International regulatory affairs and inregulatory compliance with the reputed pharmaceutical companies backed by a sound academiceducational background.During my total experience of 15+ years, I have equipped myself with all functions duringGDUFA era, which includes; Leveraged skills in CMC documentation for preparing, amending and updating the DrugMaster Files (DMFs) / CEP’s of APIs as per USFDA (Type-II & Type-V DMF’s),EDQM & Healthcare, Health Canada (Type-I CDMF’s) TGA, WHO (APIMF’s) andother RoW markets In‐depth knowledge of ‘Quality management system’ as per current good manufacturingpractices. Contribution in different quality assurance functions; participation in variousglobal customer audits and health authorities (HA) audits like USFDA, EDQM, BfArM‐Germany, ANSM‐ France, Korean FDA, Health Canada etc. An enterprising leader with outstanding decision‐making & problem-solving skills andcompetencies in leading personnel towards accomplishment of company goals Identification, screening and assessment of Genotoxic, Carcinogenic, ‘High-potencymutagenic carcinogens’ (“cohort of concern”) and other potential impurities involved inAPI’s & SM and setting suitable limits Expertise on handling global Regulatory audits for sterile and non-sterile API facilities Expertise on ‘Sterility Assurance’ and ‘Aseptic process’ of Sterile API’s/Dosage forms. Writing investigation reports with respect to API quality Management systems, ‘SterilityAssurance’ and ‘Microbiology’ related aspects Writing scientific responses on deficiencies raised by the global regulatory authoritiesespecially US FDA under GDUFA, EDQM, EU National competent authorities, HealthCanada (TPD) and customers as per current regulatory requirements. Identify the critical issues related to Regulatory & cGMP as a member of the RegulatoryAffairs and contributing to defining the regulatory strategy.