Regulatory Operations Sr. Publisher eCTD Expert

Sarada Atluri

New Jersey 908-***-**** ************@*******.*** Linkedin

Professional Summary

Accomplished pharmacovigilance publishing leader with extensive experience in global dossier management, electronic submissions, and compliance with FDA, EMA, and international regulatory requirements. Recognized Subject Matter Expert (SME) in eDMS platforms, eCTD publishing, and safety reporting. Proven ability to streamline processes, mentor global teams, and lead cross-functional initiatives that enhance operational efficiency and regulatory compliance.

Core Skills

Systems & Tools: Veeva RIM, Calyx RIM, DOMASYS, Adobe Acrobat Pro, ISI Toolbox, SharePoint

Safety Reporting & Compliance: PSURs/PBRERs, PADERs, DSURs, RMPs, PSMF, Safety Signal Reports, SDEAs

Leadership & Collaboration: Cross-functional Team Leadership, Vendor Oversight, Training & Mentoring

Process Excellence: Submission Readiness, KPI Tracking, Process Optimization, Knowledge Transfer

Professional Experience

PV Publishing and Distribution Lead

Opella, Morristown, NJ May 2023 – Sep 2025

Lead strategic planning and oversight for global publishing and distribution of PSRs, RMPs, PSMF, and Ad-hoc Safety Reports using Veeva RIM and Calyx RIM.

Serve as SME for eCTD submissions to FDA/EMA and publishing tool implementation in partnership with Regulatory Affairs.

Train and mentor vendor teams as super user on publishing systems and eDMS platforms, ensuring 100% on-time, compliant global distribution.

Track and analyze KPIs to drive continuous improvement in publishing turnaround time and compliance metrics.

Define business requirements for DMS enhancements, serving as core member for system upgrades and process optimization.

PV Publishing Specialist

Sanofi, Bridgewater, NJ Jan 2015 – Apr 2023

Managed end-to-end publishing of safety reports (PSURs, RMPs, PSMFs) within Veeva RIM and other eDMS systems.

Coordinated Electronic Table of Contents (eTOC) and Submission Content Plans (SCPs) for global dossier submissions and labeling updates.

Trained global PV teams on eDMS usage and advanced MS Word, improving document consistency and quality.

Oversaw offshore vendor publishing activities, ensuring compliance with quality standards and timelines.

Designed and maintained SharePoint site for streamlined publishing workflows and collaboration.

Led process improvement initiatives that reduced publishing cycle times and enhanced tool performance.

PV Dossier Management Specialist

Sanofi, Bridgewater, NJ Dec 2010 – Jan 2015

Coordinated publishing of global safety reports, ensuring submission-ready dossiers.

Trained colleagues and external collaborators on advanced eDMS functions and formatting best practices.

Uploaded and maintained PSUR reports for affiliate submissions and regulatory access.

Generated WMAS (Worldwide Marketing Authorization Status) reports to support global safety reporting.

Case Administrator

Sanofi-Aventis, Bridgewater, NJ Apr 2004 – Dec 2010

Registered and processed ICSRs in AWARE, managing acknowledgments and workflows across affiliates and partners.

Trained new staff to ensure seamless onboarding and workflow efficiency.

Authored Work Instructions (WINs) for case archiving, improving compliance and operational efficiency.

Education & Training

B.S., Electronics & Communication Engineering – Nagarjuna University, India

Diploma, Computer Programming – India

Web Development Certificate – Rutgers Internet Institute, NJ

Coursework: SAS, Advanced C, C++, UNIX – Raritan Valley Community College, NJ

Electrical Engineering Courses – NJIT, Newark, NJ

Contact this candidate