Experienced and resourceful Lead Regulatory Analyst in the department of Pharma Regulatory affairs with a master’s degree. Accomplished at Experienced with modules of the drug development cycle. Well-versed in numerous Regulatory drafting of Protocols, amendments, Clinical Study Reports, Informed Consent Documents, Case Report Form for the clinical studies, Periodic safety update reports, Aggregate reports etc. and perform quality control (QC) checks / proof reading of documents to meet business expectation. Strong background in Data Migration to Veeva vault (Tool). Thrives working in a dynamic environment that call for exceptional adaptability, flexibility, and effective collaboration and teamwork with and within teams.