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Shakul

Shakul



Location:India
 
Description:Having nearly 3.5 years of experience in the field of Pharmaceutical Regulatory Informatics and Regulatory Submissions (Currently Working as a Regulatory Associate for electronic submissions). As a regulatory Informatics professional my work profile includes; Responsible for the coordination and preparation of various Electronic Submissions for US FDA (eCTD Submissions) like NDA, IND, ANDA, DMF and SPL/PLR. For EMEA different types of eCTD submission Procedures like Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP) and Active Substance Master File (ASMF). And also eCTD submissions for Health Canada and SwissMedic.
 
Keywords:Healthcare Informatics FDA, EMEA and Health Canada
 
Work experience:Organization : SPIC Pharmaceuticals, Designation: Regulatory Executive Duration: 1.3 years (June 2007 to September 2008) Responsibilities: In charge of Regulatory Documentation Maintenance. Organization: TAKE Solutions Ltd, India Designation: Technical Associate for Regulatory Submissions Duration: From October 2008 to December 2009 Responsibilities: Applying Regulatory (ICH, FDA, EMEA, and Health Canada) guidelines for developing Electronic Common Technical Document (eCTD) and SPL Software. Organization: Novartis Healthcare Ltd, India Designation: Regulatory Associate (eSubmission Specialist) Duration: From December 2009 to till now Responsibilities: Taking care of all Major Regulatory Submissions including NDA and IND Submissions for USFDA. Initial Marketing Authorization (Initial MAA), Variations and PSUR submissions for European Regulatory Agencies.
 
Years of experience:4
 


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