Vignesh Rajendran Email & Phone Number

Publishing and Product License Support (PPLS) Responsible for publishing, validating, and QC of various electronic formats such as NeeS, eCTD, and Paper Submissions assuring the quality and completeness of the submissions. Having hands-on experience in regulatory tools such as Liquent Insight, LORENZ e-Validator, Global Data Management System (GDMS), Adobe Acrobat with ISI Toolbox, Office 365, SCC Compass, WSRO Swift, Ultra ISO.Assist Regulatory Associate Trainees with document-level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines. Regularly update and maintain regulatory submissions database & maintain archives.Support to regulatory submission publishing such as US-FDA, EU, and Health Canada.Expertise in US - Ad/Promo & Complex/ Major Submissions, and Performs QC for regulatory submissions.Contribute essential and viable knowledge to teams on regulatory operation technical points to assure timely and systematic management of eCTD/CTD submissions.Diversified experience and directly worked with clients. Additional roles have been performed as a Submission Specialist. where perform end-to-end Electronic & Paper submissions for the French West Africa region.