Senior Regulatory Associate

5/2015 – 9/2020

Manage daily tasks associated with publishing regulatory submissions, including bookmarking, hyperlinking and quality control of submission PDF files in accordance with FDA guidelines and other health authorities. Responsible for submitting high quality regulatory submissions to regulatory agencies
within given timelines and in accordance with regulatory guidelines. Involved in pre publishing activities like hyper linking and creating book marks by using LIQUENT SmartDesk for pdf Publishing activities (Compilation of Application as per Submission planner, Publishing of eCTD using Publishing tools (Insight
Publisher) Life Cycle Management of Drug Product (creating life cycle submission) Gained knowledge of Post Publishing activities (External linking, Validation of submission). Working within global publishing teams and performing submission publishing activities in accordance with relevant regional agency guidelines.

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