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Hanif Desai

@hanifdesai

Regulatory Operations Consultant specializing in Veeva RIM support and migration, including Documentum metadata mapping for Veeva RIM.

United Kingdom
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At FME AG, I supported Veeva RIM migration for end clients Sandoz, Takeda, and Pfizer, mapping Documentum data and metadata to Veeva RIM. I developed mapping specifications and worked with developers and business stakeholders to align business requirements with technical needs.

At Geron Corporation, I supported Veeva RIM, archived submissions and agency correspondence, maintained Submission Content Plans, and helped migrate legacy records. I also implemented system changes through Change Control and validation.

At Trizell Ltd, I configured Veeva Submissions Vault processes and document workflows for clinical and regulatory submission documents ahead of BLA and IND submissions to the FDA. This work improved Vault utilisation and documentation controls, with more users and documents held electronically.

Across regulatory publishing and systems roles, I supported eCTD and NeeS submissions, Veeva platforms, and clinical document migrations. I'm also preparing for the AZ-104 Microsoft Azure Administrator certification and have completed Microsoft Azure Fundamentals.

Experience

Work history, roles, and key accomplishments

FA

Vault RIM Expert/BA

FME AG

Nov 2024 - Jul 2026 (1 year 8 months)

Supported migration team with mapping Documentum-based data into Veeva RIM, driving metadata mapping and creating mapping specifications. Liaised with developers and business stakeholders to align requirements.

GC

Regulatory Operations Consultant

Geron Corporation

Jul 2023 - Aug 2024 (1 year 1 month)

Provided ongoing Veeva RIM support, archiving submissions and correspondences, troubleshooting issues, and maintaining Submission Content Plans. Implemented changes via Change Control and validation processes.

PG

eTMF Associate

Propharma Group

Nov 2022 - Mar 2023 (4 months)

Migrated clinical trial legacy documents from Box to Veeva eTMF, using inventories to locate files and uploading them. Conducted quality reviews and checkpoints.

AR

Business Information Systems Operations Manager

Argenx

Jun 2022 - Oct 2022 (4 months)

Ensured solutions and support structures were documented and defined Level-2 support capabilities. Developed a website for Veeva RIM education in collaboration with web design SMEs.

PS

Data Transfer Lead, Senior Regulatory Systems Specialist

PRA Health Sciences

Oct 2020 - Feb 2021 (4 months)

Supported data transfer behind a major divestment deal.

TL

Regulatory Information Management Consultant

Trizell Ltd

Mar 2019 - Oct 2020 (1 year 7 months)

Implemented efficient processes for uploading clinical and regulatory documents to Veeva Submissions Vault for BLA and IND submissions. Configured document workflows.

JL

Submission Manager & Publisher

Janssen Ltd

Jun 2018 - Nov 2018 (5 months)

Oversaw GCC and EU submissions for pharmaceutical portfolio using DocuBridge platform.

AC

Regulatory Publishing Consultant

Acorn Consultancy

Mar 2018 - Jun 2018 (3 months)

Submitted and validated NeeS and eCTD submissions for clients using Extedo eCTD manager and EURSvalidator.

GP

CMC Publisher

Genpact Pharmalink

May 2017 - Feb 2018 (9 months)

Managed prompt publication of electronic common technical documentation and non-eCTD electronic submissions for European National Licenses.

AL

Regional Submission Specialist

AbbVie Limited

Jun 2015 - May 2017 (1 year 11 months)

Coordinated submission of filings to regulatory agencies across EMEA, overseeing pre- and post-publishing phases and supporting selection of outsourced publishers.

RB

Regulatory Associate

Reckitt Benckiser

Apr 2013 - Jun 2015 (2 years 2 months)

Worked as Regulatory Associate at Reckitt Benckiser.

RB

R&D Analytical Assistant

Reckitt Benckiser

Mar 2011 - Apr 2013 (2 years 1 month)

Worked as R&D Analytical Assistant at Reckitt Benckiser.

AL

Environmental Laboratory Analyst

Alcontrol Laboratories

Aug 2010 - Mar 2011 (7 months)

Worked as Environmental Laboratory Analyst at Alcontrol Laboratories.

GL

Material Science Analyst

GlaxoSmithKline

Dec 2009 - Jun 2010 (6 months)

Worked as Material Science Analyst at GlaxoSmithKline.

GL

Data Analyst

GlaxoSmithKline

Sep 2009 - Nov 2009 (2 months)

Worked as Data Analyst at GlaxoSmithKline.

GL

Analytical Chemist - Quality Assurance

GlaxoSmithKline

Aug 2007 - Aug 2008 (1 year)

Worked as Analytical Chemist in Quality Assurance at GlaxoSmithKline.

Education

Degrees, certifications, and relevant coursework

Microsoft logoMI

Microsoft

Microsoft Azure Fundamentals, Cloud Computing

Microsoft Azure Fundamentals, completed September 2026.

LL

LinkedIn Learning

Introduction to Artificial Intelligence, Artificial Intelligence

Introduction to Artificial Intelligence, issued August 2026.

VV

Veeva Vault

Veeva Admin Certification, Veeva Administration

Veeva Admin Certification, expired November 2020.

University of Reading logoUR

University of Reading

Bachelor of Science, Chemistry

Bachelor of Science in Chemistry from the University of Reading, completed July 2009.

Microsoft logoMI

Microsoft

Microsoft Learning Path: Get started with Windows PowerShell, PowerShell

Microsoft Learning Path: Get started with Windows PowerShell.

Tech stack

Software and tools used professionally

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