Ranjith Belluri

About Ranjith Belluri

Over 16 years of experience in design, development and implementing projects in the area of Regulatory Publishing.• Over 10 years of experience in project management and submission management.• Expert in Regulatory information management system, trained on Veeva RIM systems (Submissions, publishing and submissions archive, Registrations). • Involved in requirements workshop of Veeva RIM, process documentation, process exercises, Testing, Validation, Change Control, New releases, SOP’s, Work instructions and Training Users• Data migration to newly implemented Veeva RIM. Migration Planning, specification, Verification and Deviations. • Involved in data clean up in the newly implemented Veeva System, Administration, Governance, cleaning up the duplicate documents, fixing classifications• Working experience on Veeva Vault Registration tracking.• Involved in creating impact assessment reports, related records, reports and several other activities related to registration tracking• Familiar with drug development process, FDA and ICH guidelines, regulatory submission process and application types for US, Canada and EU.• Experience in creating global regulatory submissions publishing in both paper and electronic (eCTD) format for different application types such as IND, NDA, ANDA, BLA, NDS, MAA, NeeS and CTA.• Develop, maintain and upgrade training manuals, publishing manuals, guidance documents, SOPs and WIs for different publishing processes (eCTD, CSR, SAP, IB, and Protocols).• Strong exposure in publishing tools such as Liquent\'s Insight Publisher, CoreDossier, EZsubs, ISI’s eCTD Express, ISI Publisher.• Tracking the transition project progress, working on SDLC documentation and working with all parties including business and IT teams.• Worked with software vendors and IT teams to bring new software applications, implementing them to improve efficiency for delivering high quality submissions• Working on the IQ’s, OQ’s and UAT provided by software vendors, logging issues and resolving them.• Experience in Microsoft Word formatting using the templated and word styles and making the them submission ready.• Strong exposure in reviewing and validation tools such as Global Submit’s Review and Validate, Liquent’s Insight Viewer, eCTD Reviewer, SmartDesk for PDF (a-pulse) and ISI Toolbox.• Formally trained on the Veeva Vault RIM document management system.• Advanced knowledge of EDMS, Documentum, Veeva vault RIM regulatory publishing software and MS Office Suite.• Experienced in dispatching the submissions electronically via ESG (FDA, EMA, CESP)

Experience

1. Veeva Rim Regulatory Operations Consultant

   Pacira BioSciences, Inc.

   Jan 2022 — Present · NJ, US

Education

• Dominican University

  Master's degree, Computer Science

Skills

• U.s. Food and Drug Administration (Fda)
• Protocol
• Regulatory Affairs
• Regulatory Submissions
• Documentum
• Pharmaceutical Industry
• Fda
• Requirements Analysis
• Validation
• Ind
• Electronic Common Technical Document (Ectd)
• Insight Publisher
• Document Management
• Biotechnology
• Pharmaceutics
• Isi Toolbox
• Ectd