Fazil M Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

➢Auditing the existing data with Regulatory product lead and correcting the Regulatory information in STAR.➢ Minimized the data errors and duplication occurred over the period of time to meet the agreed timelines.➢ Remediation of the data entered in the STAR system to meet the KPI➢ Comparison of migrated data to ensure the quality and accuracy of the product migrated.➢ With minimal input from manager Comparison of required data with existing data to avoid receiving "Refuse to Receive [RTR]" responses from the Agency.➢Veeva Vault Data Migration: Veeva Vault EDMS tool for Regulatory Information Management.

Bengaluru Area, India

➢ Responsible for end-to-end publishing activities and timely deliverables.➢ Understanding the overview of the project and developing the trackers and policies related to the project to expediate the submissions.➢ Expertise in US IND and NDA submission types like US General Correspondence, CMC Supplements, Labelling Supplements and IND Protocol Amendments.➢ Expertise in EU CP MRP DCP and NP procedure types for variations, renewals, and RtQ.➢ Compiled various submissions within DocuBridge and eCTDXPress for MAA, IND and NDA applications. Naming the files according to ICH guidelines and generating TOC, publishing and validating the packages.➢ Publishing the Packages in eCTD, NeES and paper/pdf format using various Publishing tools such as DocuBridge and Insight Publisher.➢ Performing Multiple Quality control checks to ensure the high quality of submission.➢ Involving in trouble shooting activities related to publishing tools and other queries.Confidential Page 3 of 4➢ Submitting the compiled submission packages to the respective HA’s such as USFDA, Canada HC, European Union using ESG Gateway, EMA Web client trader and CESP portal.➢ Delivery of published output to GRA or LRAs or the third-party vendors to ensure the timeline.➢ Profound knowledge in collecting, archiving and tracking the Clinical Trail Application (CTA) regulatory documents using Liquent Insight viewer.➢ Organizing team meetings to get project updates from managers and future plans.➢ Maintain regular communication channels to keep teams apprised of the status of submission publication activities and management of individual workload.

Bengaluru Area, India

➢Performing Pre-publishing and Post Publishing activities like merging of documents, External Linking, Magnification, Bookmark fixation, intelliQC and optimization of the document.➢ Performing Submission Readiness Check (SRC) for the regulatory documents to meet to the Health Authority criteria using Starting Point Plugin. ➢hands on experience on tools like “Smart Desk” for PDF and “ISI Toolbox” for pre-publishing activitiesPerforming Post publishing activities such as External linking and validating the submission packages using various eValidators to meet the ICH guidelines.➢Worked on Publishing activities including Annual Reports for IND/NDA Applications for USFDA and DSUR, PBER/PSUR for various MAA applications for EU and ROW region.➢ Performing QC for the Paper submission against QC checklist.➢ Liaise with senior manager to ascertain individual submission requirements for specific countries & their respective regulatory bodies for smooth dispatch.➢ Tracking the status of the submission and update the submission status in the tracker.➢ Archiving the submission in database.

Master Of Science - Ms, Biotechnology

Bachelor Of Science - Bs, Chemistry Botany Biotechnology