---
title: "Karthik V - GRA e-CTD Publisher in Bengaluru | Tal"
description: "Meet Karthik V, GRA e-CTD Publisher | Regulatory Compliance | Veeva Vault | RIM | PromoMats | MLR reviewer | PowerBI based in Bengaluru."
image: "https://tal.club/meet/karthik-v/share-image"
---

# Karthik V on Tal

## Headline

GRA e\-CTD Publisher \| Regulatory Compliance \| Veeva Vault \| RIM \| PromoMats \| MLR reviewer \| PowerBI

## About

Eli Lilly and Company relied on their expertise as a Global Regulatory Affairs e\-CTD Publisher to manage and coordinate over \+500 Ad Promo submissions, including Single Product 2253, Multi\-Product/Grouped, Cross\-Reference, and Advisory types\. Working across global and regional regulatory teams, they ensured adherence to registration requirements and regulatory standards while utilizing advanced tools such as ISI Toolbox and Lorenz Submission Validation for seamless metadata management and compliance\. With a Master’s degree in Pharmacy from the Government College of Pharmacy and certifications in Clinical Research and Data Management, they bring a robust understanding of pharmacology and regulatory frameworks\. Focused on precision and collaboration, they aim to contribute to regulatory strategies supporting the pharmaceutical industry's evolving needs\.

## Location

Bengaluru

## Work experience

GRA e\-CTD Publisher at Eli Lilly and Company, Aug 2024 \- Feb 2025 · 7 mos, Bengaluru, • Supported the end\-to\-end coordination and delivery of global regulatory submissions, including marketing applications and post\-approval lifecycle maintenance activities Ad Promo\(USFDA\), in compliance with ICH guidelines, regional regulatory authority requirements, and internal SOPs\. • Collaborated with Regulatory Affairs, CMC, Medical Writing, and publishing stakeholders to ensure timely document collection, quality review, and submission readiness within agreed timelines\. • Executed eCTD compilation, formatting, hyperlinking, bookmarking, and validation across Modules 1–5 to support regulatory authority submissions and maintenance activities\. • Performed comprehensive regulatory quality checks and validation using Lorenz eValidator, ISI Toolbox, and Veeva Vault RIM, proactively identifying risks and resolving issues prior to submission delivery\. • Supported post\-approval lifecycle activities, including variations and regional maintenance submissions, by ensuring document accuracy, metadata completeness, and compliance with regulatory guidelines\. • Partnered with cross\-functional teams to track submission progress, manage dependencies, and escalate risks with potential impact on submission timelines or quality\. • Contributed to process improvement initiatives by troubleshooting validation errors and optimizing publishing workflows, improving submission readiness and operational efficiency\. Key Achievement: \- Supported over 500 global submission deliverables with zero QC deviations, improving file readiness efficiency by 15% through proactive issue resolution and standardized validation practices\.

Junior Associate at Himalaya Wellness Company, Nov 2021 \- Apr 2022 · 6 mos, Bengaluru, Karnataka, India, • Prepared, reviewed, and maintained Batch Manufacturing Records \(BMR\) and Standard Operating Procedures \(SOP\), ensuring compliance with Good Manufacturing Practices \(GMP\)\. • Conducted routine and periodic maintenance and calibration of production equipment to maintain operational efficiency and adherence to quality standards\. • Monitored and implemented quality control and assurance protocols to support consistent product quality and regulatory compliance\. • Managed and trained production staff, fostering a culture of adherence to SOPs, safety practices, and performance excellence\. • Played a pivotal role in audits and inspections by maintaining accurate documentation and ensuring regulatory readiness\. • Identified and implemented process improvements to enhance efficiency and minimize production downtime\.

Production Trainee at Karnataka Antibiotics & Pharmaceuticals Limited, Peenya, Bangalore, Jan 2021 \- Nov 2021 · 11 mos, Bengaluru, Karnataka, India, • Managed production staff to ensure timely delivery of high\-quality pharmaceutical products while optimizing costs\. • Enforced company policies and implemented process improvements, enhancing overall efficiency and product quality\. • Conducted regular quality inspections and ensured compliance with Good Manufacturing Practice \(GMP\) standards\. • Developed strong organizational and communication skills while fostering a safe and clean working environment\.

## Education

Master's degree, Pharmacology, Government College of Pharmacy

Bachelor of Pharmacy \- BPharm, Pharmacy, Mallige College of Pharmacy

[View the original profile](https://tal.club/meet/karthik-v)

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