Summary
Overview
Work History
Education
Skills
Languages
Affiliations
Disclaimer
Timeline
Generic

Nikhil Sai Marri

Tirupati

Summary

Seeking a challenging position as a GRA CMC Regulatory Associate, where I have up to 3.8 years of experience in regulatory editing and publishing from Module 1 to Module 5.

Overview

4
4
years of professional experience

Work History

CMC Editing Associate

Eli Lilly and Company
Bangalore
04.2024 - Current
  • Editing CMC word documents in Module 3 submissions for the US, CA, and EU regions.
  • Creating the binders for CTA and IMPD's submissions with the help of the content plan in RIMS.
  • Checking the alignments, spacings of tables and figures, and updating section headings in Word, as per DS and DP requirements in Module 3.
  • Preparing a DSUR AR memo link for U.S. regions from the Vault RIM submissions.
  • Binders creation and editing CMC Word documents for RTQ submissions.
  • Submitting HAQ database recordings for RTQ documents in the Vault RIM.
  • Creating cover pages for clean and annotated documents for the EU, US, and UK regions.
  • Expertise in handling ISI Toolbox, Microsoft Word, and Veeva Vault.

Junior Regulatory Affairs Associate

Parexel International
Bangalore
09.2021 - 03.2024
  • Publishing, Dispatching, and archiving submission to various regions like US, EU, CH, GCC and other Row regions
  • Expertise in US, IND, NDA Submission types like US General Correspondence, CMC Supplements, and IND protocol Supplements
  • Expertise in NP, CP, MRP, and DCP procedure types for variations and renewals
  • Expertise in Swiss and GCC eCTD Submission
  • Publishing Ad promo OPDP Professional and consumer submissions for US
  • Expertise in handling Docubridge, ISI Toolbox, Microsoft word, Veeva vault Liquent insight and smart desk
  • Creating hyperlinks, bookmarks, auditing, and editing for the per and post eCTD Pdf documents
  • Formatting heading styles, table captions, header and footer styles, Cross- references, adjusting spaces for PSUR, DSUR, SMP, RMP word documents by using author template
  • FDA Dispatch of Mutual recognition procedure, Central Procedure, and AD promos via ESG to EMA
  • Dispatch of National Procedure, Mutual recognition procedure, Central Procedure via CESP portal
  • Creating eCTD publishing binders as per STN's and archiving documents in Veeva vault for various regions like US, EU, CH, GCC and other Row regions

Education

Master's degree - Drug Regulatory Affairs

Jawaharlal Nehru Technology of University
A.P. India
09-2023

Skills

  • Time management
  • Problem solving
  • Adaptability under pressure
  • Leadership skills
  • Document formatting
  • eCTD publishing

Languages

  • English
  • Hindi
  • Telugu

Affiliations

  • Won the first prize for proposing the idea of enhancing efficiency and quality through automation, internal hyperlink creation for CMC Word documents at Innoventia 2.0

Disclaimer

I hereby declare that the above details are true and faithful to the best of my knowledge and belief

                                                                                                                            Signature

                                                                                                                            Nikhil Sai Marri

                                                                                                                                                        

Timeline

CMC Editing Associate

Eli Lilly and Company
04.2024 - Current

Junior Regulatory Affairs Associate

Parexel International
09.2021 - 03.2024

Master's degree - Drug Regulatory Affairs

Jawaharlal Nehru Technology of University

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