Kiran Kumbar

Core Publishing

• Oversee end-to-end publishing activities for major and minor submissions For US,CA,EU,Swiss,AU,NZ, GCC,ROW, (NDA, ANDA, BLA, MAA, IND, DMF, variations, renewals, and supplements).

•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 the 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.

• Ensure compliance with global health authority requirements (FDA, EMA, Health Canada, MHRA, TGA, WHO, etc.).

• Perform document formatting, hyperlinking, bookmarking, and validation using industry-standard publishing tools.

• Ensure on-time dispatch of submission packages via electronic gateways (e.g., ESG, CESP, MHRA portal).

Quality & Compliance

• Conduct quality reviews of submissions prepared by junior publishers, ensuring adherence to specifications and eliminating validation errors.

• Maintain submission archives, version control, and audit-ready documentation.

• Implement best practices and continuous process improvements to strengthen publishing quality and compliance.

Workload & Team Support

• Manage daily workload distribution within the publishing team to meet timelines.

• Provide guidance and technical support to junior publishers and new team members.

Metrics & Process Improvement

• Generate and track submission metrics (cycle times, on-time delivery, volume, quality compliance) for management review.

Technology & Innovation

• Participate in testing, validation, and implementation of publishing tools version upgrades.

• Provide feedback to IT and system vendors in enhancing publishing tool functionality.

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