Ramya Nataraj

Regulatory Affairs Executive @Imedglobal Corporation

Bengaluru, IN

Publishing of eCTD, Paper Output/Dossiers and NeeS Submissions to various Regulatory Agencies, Clinical Publishing of Module 5 Clinical Study Reports. Handling of DCP, MRP, CP and National Submissions.• Hands on experience on Initial Marketing Authorization Application(MAA), Baseline Submissions for EU and Post Approval activities like Annual Reports and Amendments, Variations - Type II, 1A, 1AIN and 1B (National, DCP & MRP), Response(Supplemental Information), Answer to HA Questions (Responses to HA), PBRER/PSUR(EU), DMF Submissions for US and European Union markets.• Publishing of Clinical Study Reports, Investigators Brochure, Clinical Trial Authorisation(CTA), Periodic Safety Update Reports, Development Safety Update Reports, Pharmacovigilnce Reports using the Liquent Insight Publisher.• Submission of Approved Final Published Dossiers to CESP and EMA Gateways.• Hands on experience on eCTD, NeeS & Paper PDF for both Europe and US regions(Modules 1,2,3,4 and 5). • Performed Report Level Publishing,Document Level and Submission Level Publishing, Preparing Submission ready documents which includes Bookmarking and Hyperlinking, Quality Control Activities on Published Outputs Documents for the completeness, hierarchy and target of bookmarks, destination of links using ISI Toolbox. • Performing QC on Submissions and Fixing Validation Issues• Responsible for Handling Structured Product Labeling, eCTD, NeeS and Paper Submissions to Regulatory Agencies.

ACRI

PG Diploma

M.V.J. College Of Engineering

Bachelor of Technology (BTech)