Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

Roshani Jain

Bangalore

Summary

Regulatory Affairs professional with three years of experience and expertise in Veeva Vault RIM, specializing in Core and Affiliate Labeling for US and CA markets, CT IFU, Image Library, and Artwork creation in BLUE software, alongside eCTD and non-eCTD submissions and SME for TVT tool.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Associate- GLO Labeling

Eli Lilly, Bangalore
09.2023 - Current
  • Contributing to the end-to-end labeling submissions.
  • Lead the development and maintenance of Core Labeling: CDS, CDL, CMC, CLC, and Affiliate Labeling: USPI, IFU, carton, and container labels.
  • Business Subject Matter Expert for TVT (Text Verification Tool).
  • In BLUE software, creating artwork projects, asset validation, QC for artwork, and approval of artworks.
  • Responsible for the creation of the Image Library for IFU, Core, and MML share packs.
  • Responsible for label assessment tasks.
  • LabelNet Data Transfer.
  • RIM Veeva Vault: Creating the event, activity, or submission record, adding metadata, initiating workflows, maintaining the lifecycle of submission, and matching the content plan, etc.

Regulatory Specialist, Submission Assembly

GlaxoSmithKline, Bangalore
08.2022 - 08.2023
  • Involved in the end-to-end submission process in Veeva Vault RIM.
  • Editing metadata, creation of a submission content plan, finalization of the CP, and detailed quality check of the dossier (XML operators, versions, and documents matching in the submission content plan).
  • MSR authoring for the preparation of a draft cover letter and application form for EE, EU nationals, Nordics, and the UK.
  • Drive the submission and delivery process to ensure timely dispatch and archival of submissions, as per the agreed timelines, by having communication with stakeholders like CMC, LoC/PoC, Labeling, MSR, and Global Publishing teams.

Intern

NuLife Pharmaceuticals
Pune
11.2020 - 12.2020
  • Overseeing the Quality Control and Quality Assurance department.

Education

Master of Pharmacy - Pharmaceutical Quality Assurance

Manipal University
Manipal
06-2023

Bachelor of Pharmacy -

Poona College of Pharmacy, Bharati Vidyapeeth
Pune
09-2021

Skills

  • Veeva Vault RIM
  • Power BI
  • Text Verification Tool
  • Core labeling
  • Labeling submission (US and CA)
  • eCTD and non-eCTD (ROW) submissions
  • Submission coordination
  • BLUE

Accomplishments

  • H2 2024 Top Leader Award - Category: The Instinct Seeker Award
  • Global Recognition Award: ROW market for optimizing the process and schooling the LoCs
  • Recognition for disciplinary CR, cultural secretary, class representative

Certification

  • Specialisation in drug discovery, drug development, and drug commercialisation
  • Specialisation in clinical trials operations
  • Specialisation in introduction to data science
  • Work smarter with Microsoft Excel course
  • Introduction to AI

Timeline

Associate- GLO Labeling

Eli Lilly, Bangalore
09.2023 - Current

Regulatory Specialist, Submission Assembly

GlaxoSmithKline, Bangalore
08.2022 - 08.2023

Intern

NuLife Pharmaceuticals
11.2020 - 12.2020

Master of Pharmacy - Pharmaceutical Quality Assurance

Manipal University

Bachelor of Pharmacy -

Poona College of Pharmacy, Bharati Vidyapeeth

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Roshani Jain