Summary
Overview
Work History
Education
Skills
Timeline
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Kiran Kumbar

Bangalore

Summary

Agile and result-driven Clinical Publisher with 7+ years of experience in Electronic Submission Publishing for US, EU, GB,Canada, AU, NZ, ICO, GCC, ROW market for eCTD, Nees and Paper Submission

Seasoned Regulatory Affairs Associate with comprehensive background in biotechnology and pharmaceutical industries. Experience includes overseeing regulatory submissions, maintaining compliance with FDA regulations, and coordinating efforts between research and development teams. Strengths lie in solid understanding of international regulatory guidelines, ability to manage multiple projects simultaneously, and strong communication skills. Past roles have demonstrated significant impact on efficiency of regulatory processes.

Overview

7
7
years of professional experience

Work History

Senior Regulatory Affairs Associate

Parexel International, Bangalore
Bangalore
03.2019 - Current
  • Review of documents and compilation/preparation of eCTD and pCTD final dossiers and Core Packages for Pharma and Vaccine Products - US,CA,AU,NZ,ROW, GCC, Renewal, MAH and Mfg Name change, PSUSA, Swiss, CTA, CMC Lifecycle variation filing, WorkSharing procedures for EU market
  • Review of documents and compilation/preparation of eCTD and pCTD Renewal Core Packages for Global Market
  • Validating the published outputs with CTD validation tools - EURS validator and Lorenz eValidator according to the current regulatory guidelines
  • Preparing and maintaining regulatory documentation databases, regulatory submission and archival into Documentum system Veeva-Vault
  • Preparation of submission ready pdf documents, creating bookmarks and internal and external hyperlinks using Adobe acrobat plug-ins (Smart desk and ISI Toolbox)
  • Expertise on Applications/Tools - Insight-Publisher, Insight-Viewer, Docbridge,Ectd Manager, Veeva-Vault, Adobe-Acrobat and plug-ins Smart desk and ISI Toolbox, EURS Validator, Lorenz eValidator
    • Supports in quality check for Project Data Metrics

Senior Process Associate

Tata Consultancy Services (TCS), Pune
Pune
02.2017 - 03.2019
  • Regulatory Publishing
  • Produces high-quality dossiers by handling MS Word, PDF, creates cross-references, table of content, performs bookmarking, hyper-linking, and tables of content creation etc according to FDA guidelines
  • Publishing of Regulatory Documents and Reports according to client specific guidelines.
  • Submission ready document using on MS Word and PDF using tools ISI Toolbox, SmartDesk, InSight Publisher, InSight for Viewing
  • Management of Regulatory Information for Global submissions
  • Uploading regulatory documents in document management system and classifying according to defined hierarchies and naming conventions from work requests, supports client Archival
  • Building Virtual structures within document management systems according to defined table of Contents.
  • RIM VeevaVault - submission document management, product registration management, health authority correspondence and commitments, submission archiving

Education

Master of Science - Pharmacy

B,L,D,E,A,S Collage of Pharmacy
Bijapur
07-2016

Skills

  • Ectd, Nees, Paper Publishing
  • Product Lifecycle Management
  • Submission Dispatching to HA
  • Stakeholder Communication
  • Document Review
  • Training and mentoring
  • Regulatory Submissions

Timeline

Senior Regulatory Affairs Associate

Parexel International, Bangalore
03.2019 - Current

Senior Process Associate

Tata Consultancy Services (TCS), Pune
02.2017 - 03.2019

Master of Science - Pharmacy

B,L,D,E,A,S Collage of Pharmacy

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