SWAPNIL SONWANE

Experience

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  Tata Consultancy Services

  Jul 2019 - Jun 2021

  Regulatory Affairs Specialist

  Worked as Regulatory Affairs Specialist, Lead publisher and SPOC Managed on high quality eCTD compliant activities on various clinical and safety documents.Perform Submission ready and Publishing of various Safety and efficacy documents like Clinical study reports, DSUR, IBs, etc.Perform Bookmarking and Internal/External hyperlinking.Submission Publishing activities for US Submission:-Having good knowledge of Submission level publishing workflow, eCTD modules and their structure.Types of Submission.Review, Compilation ,Publishing and Submission of US application Like IND, NDA in eCTD.Compiling document using e-CTD express and Docubridge and cross-reviewing output file.Validation of compiled output by Lorenze-Validator.Submit the report through ESGGateway. Show less

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  Cognizant

  Jun 2021 - now

  Senior Process Executive

  Perform document management activities for regulatory submissions. Understanding, compliance checking and Document Publishing of Clinical Study Report (CSR), Risk Management plan (RMP), BD V-doc, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), License Renewals Safety Reports, Periodic Adverse Drug Experience Report (PADER). Safety Summary Reports (SSR), All clinical, safety and Regulatory Documents.To Review, Publishing, compilation and technical quality control clinical and safety reports by using publishing tools. Compliance checking and creating citations of Literature reference. Submission readiness of Clinical Study reports, Legacy clinical study reports, DSUR. To perform Redaction activity of eCTD documents as per client requirement.Independent QC of client published documents. To perform formatting, hyperlinking, uploading, archiving and e-signature initiation activities on word documents such NIS reports, NIS Protocol. US eCTD CRF assignment and hyperlinking.QC/QA of published documents for compliance with electronic submission requirements. Assist with the metrics, archiving electronic documents in the eDS, and the creation/review of process documentation. Ensure that documents are processed and issued in accordance with timelines Perform document publishing activities on the assigned document in a timely and efficient manner. Perform hypertext linking for the documents (Internal and Submission Level Links via Publishing Tool) in the client application. Also perform a quality check of the Bookmarks and hypertext links and do necessary modifications in the client Application, when necessary. Generate queries to clarify and improve the quality of the output. Show less