Jayanth A Email & Phone Number

Experienced RA Professional: Comprehensive Expertise in Submission Coordination, CMC Authoring & Publishing.As a seasoned regulatory affairs professional, I possess extensive end-to-end experience in submission coordination, CMC authoring, Module 1 compilation, and the management of initial submissions as well as post-approval changes (EU- Variations), Publishing.Core Competencies:CMC: M1 Compilation for post approval and initial submissions, M3 Review (ICH -Q), due diligence report prep'n, variations filings &APQRs prep'n.Veeva Vault RIM: Proficient in handling the full lifecycle of regulatory processes, including managing change events, creating joins, linking related records, uploading documents to the library, and executing both GCP, dispatch & SCP tasks efficiently.Document and Submission Preparation: Expertise in advanced Word formatting (manual and template-based) and eCTD PDF publishing using Adobe Acrobat DC Pro, ISI Toolbox, and Evermap. Skilled in compiling and publishing aggregated reports, ensuring compliance with regulatory standards.Publishing and Submission Management: Proven track record in comprehensive publishing activities using Lorenz docuBridge and Extedo eCTD Manager, including document compilation, validation, troubleshooting, dispatch, and submission to regulatory authorities.Implementation Notifications: Experienced in authoring precise and compliant implementation notifications for regulatory submissions, ensuring accurate communication of amendments and updates.