Shruthi Velga

About Shruthi Velga

Graduate in Pharmaceutical Science(s) with more than 5 years of experience in Regulatory affairs eCTD submissions. • In-depth knowledge in preparing, reviewing of eCTD submissions as per ICH, Health Canada, FDA, and Global regulatory guidelines. • Hands on experience in Document level (DLP) and submission level publishing (SLP). • Expert in using eCTD software for NDAs, ANDA, NDS, ANDS, S/NDS, DMFs, INDs, CTAs, DINs and NCs. • Experience in completion of high-quality submission in eCTD, NeeS and Paper format as per regulatory guidelines within the timeframe. • Expertise in validation of eCTD submission using validator (LORENZ) and correcting the errors. • Technical expertise in Document Management system (DMS) and Publishing software. • Specialize in creating book-marks and links using Adobe Acrobat and ISI toolbox. • Experience in preparation and management of eCTD dossier and eCTD lifecycle. • Comprehensive knowledge in gap analysis-review submission ready documents as per 5 modules of eCTD. • Experience in compiling and filing post approval submissions for FDA and TPD. • Working knowledge on ESG gateway for FDA and EU. • Trained and monitored new and current employees in eCTD submissions using eCTD software.

Experience

1. Data Engineer

   Pacific Gas and Electric Company

   Jun 2022 — Present

Education

• The University of Texas at Dallas

  Master's degree, Pharmaceutical Sciences

  2015 — 2017

• Jawaharlal Nehru Technological University

  Bachelor's degree, Pharmaceutical Sciences

  2012 — 2015