@harigiri
Regulatory affairs specialist publishing and validating global pharma eCTD submissions.
IndiaI’ve spent up to 11 years in Regulatory Affairs and Operations within the global pharma space, including submission publishing, compilation, and life cycle management of eCTD and core packages across US, Europe, Australia, Canada, and GCC.
At Parexel International in Bangalore, I work with eCTD tools like eCTDxpress, Veeva Vault, and ISI publisher, validate outputs with EURS/Lorenz validators, and manage periodic safety report end-to-end workflows.
Work history, roles, and key accomplishments
Responsible for submission publishing and compilation of eCTD and Core Packages for Pharma, including renewals, variations, and PSUSA for EU market.
Compilation, publishing, review, submission and life cycle management of eCTD submissions for US, Europe, Australia, Canada and GCC.
Performed pre and post document level publishing activities including bookmarking, hyperlinking, and PDF properties using ISItoolbox.
Ranbaxy
Jul 2013 - Mar 2014 (8 months)
Worked as Executive in Regulatory Affairs department.
Meyer Organic Pvt Ltd
Oct 2012 - Jul 2013 (9 months)
Worked as Medical Representative.
Degrees, certifications, and relevant coursework
Bachelor of Pharmacy, Pharmacy
Grade: 62%
Completed Bachelor of Pharmacy with 62%.
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