Virendra Bonde

Drug Regulatory Affairs Professional with extensive experience of Regulatory eCTD submission publishing, submission management, life cycle management, RIMS and dispatching global regulatory submissions compliant with Health Authority electronic requirements.
Technical Proficiency:
Tools/Software: LORENZ DocuBridge | LORENZ eValidator | LIQUENT InSight Publisher | LIQUENT InSight Validator | ESG WebTrader | CESP Portal | UK MHRA Portal | RIM Veeva Vault | Adobe Acrobat Pro | ISI Toolbox & SmartDesk
Certification – Lean Six Sigma Green Belt and Lean Bronze Certified.

Genpact India, Mumbai | Sep 2023 to May 2024
Manager – Regulatory Submission Publishing:
• Hands-on experience in handling Lorenz DocuBridge, Adobe Acrobat Pro, ESG Webtrader for US submission publishing.
• Manage the workload capacity and team with ever changing deadlines/requirements with ability to assist, support & 
shadow team member of the team where required.
• Performed Peer QC of submission output in accordance with agreed process, timelines, format and standard. 
• Maintain regular communication channels to keep teams apprised of the status of submission publishing activities and 
assigning, management of workload.
• Built various eCTD submissions for NDA & IND applications. Import submission ready files from RIM into their specific 
module folders, file tagging, leaf title modification, bookmarking and hyper-linking, quality assurance.
• Worked on the building, compiling, publishing, reviewing and dispatching electronic IND and NDA/BLA submission 
including of Promotional Labeling, Annual Report, DSUR, New Protocol, Protocol Amendments, IND Safety Reports, 
PADER/PBRER, Investigator Brochures and various other documents submitted routinely to the FDA.
Performed the archival of submission after receives the Acknowledgements from USFDA.
• Actively involved in submission management and regulatory strategy for future regulatory submission.
• Working with clients on the operational ground and manages day-to-day deliverables ensuring quality and TAT. Leading 
the client meeting, addressing their requirement, ensure effective and smooth movement of the project.
Sandoz, Hyderabad | Sep 2022 to Sep 2023
Senior Specialist – Regulatory Operations (Submission Publishing):
• Hands-on experience in handling Lorenz DocuBridge, Adobe Acrobat Pro, CESP Portal, UK MHRA portal for Electronic 
submission publishing.
• Upload submission ready documents (M1 to M5) in electronic document system with correct metadata, add into 
compilation binder, and finalize it.
• Building, compiling, publishing, reviewing and dispatching/submitting eCTD submission documentation package for 
initial submission, HAQ response, validation response for submission types like Variations (EU and UK), National 
Variation, Work-sharing, Grouping, Baseline in compliance with Health Authority requirements in European and 
National procedure.
• Responsible for update the submission status data in the regulatory information management database and maintain the 
eCTD lifecycle.
• Maintain communication network with regulatory functions including country organizations, regulatory stakeholders, and 
health authorities.
Tata Consultancy Services, Pune | Jul 2014 to Aug 2022
Business Process Lead - Submissions publishing:
• Hands-on experience in handling RIM Veeva, LIQUENT InSight Publisher, Adobe Acrobat Pro (ISI Toolbox & 
SmartDesk), ESG Webtrader, MS Office Word for eCTD submission publishing and documents level publishing. 
• Built various eCTD submissions for NDA and IND applications. Import submission ready files from RIM into their 
specific module folders, file tagging, leaf title modification, bookmarking and hyper-linking, quality assurance.
• Performed the uploading, editing, versioning, reclassifying, approval workflows of regulatory submission documents (M1 
to M5) and created the Regulatory Objective, Submission, Submission Content Plan (CTD format) in RIM Veeva for 
Regulatory submissions. Performed proper assigning, cross-linking, uploading of regulatory documents in Submission 
Content Plan in RIM from eTMF and other sources.
• Worked on the building, compiling, publishing, reviewing, and dispatching electronic IND and NDA/BLA submission 
including of Promotional Labeling, IND Safety Report and Protocol Amendment New Investigator (PANI) submitted 
routinely to the FDA. Performed the archival of submission after receives the Acknowledgements from USFDA.

Worked with documents owners to ensure internal templates and guidelines are used for documents creation. Performed 
Word and PDF formatting and ensure quality control checking of documents before the regulatory submissions.
• Performed publishing and quality checks (MS Word & PDF) of Clinical Study Report (ICH E3 format).
• Experienced in submission management, planning activities and responsible for continuous engagement with client and 
stakeholder by email/call to ensure quality and timelines of regulatory submissions.
• Actively involved in conducting all process trainings & query resolution, process improvements, CAPA preparation,
internal error defect log, internal & client meetings, monthly data matrix calculation, Business Continuity Plan.
Pharmalink Consulting, Mumbai | April 2012 to July 2014
Regulatory Affairs Officer:
• Supporting Global CMC teams for regulatory submissions by preparing the CMC (module 2 & 3) documentation for 
Registration Dossier in CTD, ACTD and eCTD compliance format
• Prepared the CMC documentation package for Variation and renewal for EU market.
• Reformatting information from old dossier format into CTD and ACTD format.
Bliss GVS Pharma, Mumbai | May 2011 to April 2012
Regulatory Affairs Trainee:
• Preparation of Drug Product Registration Dossiers in CTD, ACTD & Non-CTD format for Europe, ASEAN and CIS 
market. Worked on accurate response to RFIs and effective communication for approval.
• Review master documents such as Specifications, BMR, Validation protocol & reports, Stability data and Dissolution
protocol & reports for its regulatory adequacy before implementation.
• Coordination with Research and development, QA, QC and production for regulatory work.
Watson Pharma, Mumbai | December 2010 to May 2011
Analytical Research & Development Officer:
• Conducting Analytical research & development for formulations. Ensuring completion of projects on time.
• Handling the laboratory instruments and equipments relevant to Analytical research & development.
• Maintaining the technical documents (laboratory notebooks, instruments logbooks, training records..etc.)
Umedica Laboratories, Mumbai | February 2010 to November 2010
Analytical Research & Development Officer:
• Conducting Analytical method development and validation.
• Prepare the technical documents COA, FPS, AMVP & AMVR.
• Perform the stability and drug-excipients compatibility study and report preparation. 

M. Pharmacy…………………..