Devendar V

About Devendar V

Hands on experience in end-to-end publishing process, eCTD and NeeS submissions• Experienced in all types of publishing activities include eCTD submission for EU, US, and Canada• Perform various Post Publishing activities like external linking, Publishing (Paper and eCTD) QC and Validation (using various tools like Smart desk, Docubridge, Lorenz) of submissions and fixing any issues encountered during the process• Experience in Regulatory Publishing using DocuBridge, eCTD Manager, ISI Tool Box, Veeva Vault, Adobe Acrobat Professional, Lorenz Validator and Smart Desk for PDF a liquent tool• Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines• Knowledge of internal and external publishing standards for US, EU, and Canadian submissions• Publishing activities including Annual Reports for IND/NDA Applications for USFDA and DSUR, PBER/PSUR for various MAA applications for EU and ROW region• Collaborative knowledge of eCTD publishing for US-FDA supplements/ amendments, IND- NDA, Annual reports• Involved in dispatch of submissions to various agencies (ESG gateway US and Canada, EMA), Safesend and CESP• Submission Readiness Checks (SRC) for Editing and Reviewing PDF/Word-documents quality as per agencies requirements

Experience

1. Regulatory Affairs Officer 1

   IQVIA

   Dec 2025 — Present · Hyderabad, IN

Education

• Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal.

  M.Pharmacy, Pharmaceutical Administration

  2016 — 2018