Experienced in Drug Regulatory affairs and Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Skilled in U.S. Food and Drug Administration (FDA), Abbreviated New Drug Application (ANDA), CMC Regulatory Affairs, Regulatory Information management (RIMs) Post approval changes, Variations, Annual reports. Highly skilled Regulatory Affairs Specialist with extensive experience in preparing and reviewing of eCTD, CTD & Country specific dossiers. Proficient in creating and updating application, event, regulatory objective, Registration and Submission Content plan in Veeva.  Demonstrated expertise in managing & coordinating the preparation of regulatory documents to facilitate the regulatory submission activities such as initial submission, Renewals and response to objections. Coordinate for Technical data compilation of followings- New Projects of ANDA Compilation of Dossier for Submission Regulatory Information Management (RIMs) Component & Complex Publishing and Primary Publishing Activity Submission Management Post approval Changes Annual Reports Site Transfer ProjectsQuality management system, Process Validation, and Batch Release. Exposure in Regulatory document Review, Compilation and submission / Publishing for CSR/CPSR, ANDA etc, Perform Primary Publishing or assembler activity using ISI Toolbox, Adobe Acrobat Professional required before Submission Publishing to regulatory authorities. Hands on Veeva-Clinical and Regulatory Vault and IMMS.Strong Regulatory Affairs professional with a Master of Pharmacy in Pharmaceutical Analysis from Dr.Babasaheb Ambedkar Marathwada University Aurangabad.