Hanif Desai - Regulatory Operations- Pharmaceuticals, Desai Regulatory Services LTD

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Work Background

Geron CorporationRegulatory Affairs Operations Consultant

Jul. 2023London, England, United Kingdom

DESAI REGULATORY SERVICES LIMITEDManaging Director

Nov. 2015Slough, United KingdomFounded Desai Regulatory Service to provide regulatory information management, submission and publishing services on an interim / project basis to pharmaceutical/healthcare organisations. More information can be found in the link below. Alternatively please contact me at info@desairegulatoryservices.co.uk

FreelanceUpdated CV

Apr. 2021Updated CV

Mereo BioPharmaVeeva Vault eTMF Manager and Document Solutions

Jan. 2023 - May. 2023London, England, United KingdomClinical Study site completeness reviews Document migration of Legacy Studies User access management Archiving of legacy studies Assessing impact of Veeva Releases

ProPharma GroupVeeva eTMF Regulatory Affairs Associate

Nov. 2022 - Mar. 2023Beaconsfield, England, United KingdomMigration of Cliinical trials legacy documents to Veeva eTMF

argenxBusiness Information Systems Operations Manager

Jun. 2022 - Oct. 2022• Define the Support model necessary to ensure that our SaaS-based platforms and solutions run efficiently. • Fully participate in the requirements definition and implementation of all applications in the DDQ (discovery, development and quality) domain space. • Ensure all solutions and support structures are fully documented. • Lead the successful Release Management for DDQ platforms/solutions. • Ensure ServiceDesk has sufficient Knowledge Articles to provide Level-1 activities. • Ensure Business-side Level-2 support capabilities are defined, staffed, integrated into the application support escalation process. • Establish strong relationships with all levels of the DDQ organizations at Argenx to deliver value-added solutions that work at the operational/execution level.

CarealizeVeeva Functional Analyst

Mar. 2021 - Apr. 2022United KingdomVeeva Functional Analyst at Carealize: • Act as a functional analyst for Veeva Vault for Clinical, Quality and Regulatory. • Provide support, follow up the releases and collect, follow-up, execute changes via the change control process. • Authoring the technical configuration/solution aspect in response to a change request. • Where applicable, authoring and performing IQ and UAT prior to executing changes. • Handling and responding to to User issues and request via ServiceNow • Manage user licenses and security profiles within Quality Docs using Varonis Data Privilege and User Provisioning Task. • Monitoring the accuracy of Person Record HR Data via Migration from SF to Person Record using Vault Load functionality. • Migration of Training assignments from Person to Person using Vault Load and Vault Extract functionality • Managing and coordinating 3x releases with multiple stakeholders

PRA Health SciencesSenior Regulatory Systems Manager-Data Transfer Lead

Oct. 2020 - Feb. 2021London, England, United KingdomData Transfer Lead: Supporting the data transfer behind a major divestment deal Acts as primary point of contact for a divestment deal with the client, buyer and partners Define the scope of the data being transferred Develops and maintains the data transfer tools Maintain data transfer plans and support the project manager with communications Works with the knowledge holders and partners to prepare data and documents for transfer to the buyer

TRIZELL LTDRegulatory Information Management Consultant

Mar. 2019 - Oct. 2020ChinnorEngaged to implement more efficient and streamlined processes for uploading submission documents to Veeva Vault in preparation for major submission to FDA. ⚬ Work closely with multiple functions to update Veeva Vault RIM system. ⚬ Write and develop SOP on utilisation of Veeva Vault. ⚬ Develop, configure and maintain mechanisms / processes within Veeva Vault for all documents and information to be transferred to RIM system. ⚬ Manage data migration from old EDMS to current RIM system. Support User Acceptance Testing for Veeva Vault releases and carry out impact assessments. ⚬ Act as main point of contact for all user related issues within Veeva Vault and provide training and guidance to users. ⚬ Attended 2-day Veeva Vault R&D conference in Barcelona to share best practise and be updated on latest RIM processes Obtained Veeva Vault Platform Fundamentals certificate May 2019. Providing Global Regulatory Affairs Operations support for Regulatory Information Management (RIM) system and associated activities. -Works closely with multiple functions to update Veeva Vault RIM system. -Author and developer of SOP on using Veeva Vault. -Manage the transfer of data from old EDMS to current RIM system. -Develop, configure and maintain mechanisms/processes within Veeva Vault for all documents and information that will be transferred to RIM system. -Training and guiding users on the usage of Veeva Vault. Act as the main contact for user related issues within Veeva. -Support User Acceptance Testing for Veeva Vault Releases and carry out impact assessments. -Liaise with the Veeva vendor in terms of identifying future business needs, training needs and troubleshooting. -Participate in data quality reviews to ensure accurate and complete RIM data -Data entry and data management. -Liaise with the 3rd party publishing consultancy with regards to workload, resources and timelines. -Identifies ways to streamline the document management process.

IpsenPublishing Projects Coordinator

Nov. 2018 - Mar. 2019Abingdon, Oxfordshire, United KingdomEngaged as Publishing Project Coordinator to provide publishing and submission management support to the operations team covering EU and ROW submissions, using Extedo eCTD Manager and Veeva Vault. Reported to Senior Publishing Manager. ⚬ Published consistently on time without validation errors (50 documents per publish and 10 license applications per month for a period of 3 months. ⚬ Created internal and external hyperlinking of documentation with no errors.

Janssen Inc.Regulatory Submission Manager/Publisher/ EMEA-Emerging Markets (EM) Dossier Planner & Publisher

Jun. 2018 - Nov. 2018High Wycombe, Buckinghamshire, United KingdomEngaged as Emerging Markets Submission Manager & Publisher to oversee GCC and EU submissions for pharmaceutical portfolio. ⚬ Utilised Liquent Insight platform to publish submissions.

Acorn Regulatory Consultancy Services LimitedRegulatory Publishing Consultant

Mar. 2018 - Jun. 2018Slough, United KingdomEngaged to submit and validate NeeS and eCTD submissions for Acorn’s clients using Extedo eCTD manager and EURSvalidator. ⚬ Completed 2 x European National NeeS variation submissions (Belgium and Austria) and 1 x NeeS PSUR for France. ⚬ As part of publishing process, created and quality controlled 500 external document hyperlinks for an Initial Application within 4 days.

Genpact PharmalinkCMC Publisher

May. 2017 - Feb. 2018Maidenhead, Berkshire, United KingdomEngaged to manage prompt publication of electronic common technical documentation and non-eCTD electronic submission for European National Licenses. ⚬ Processed and executed 50% of data management requests, collaborated in managing regulatory data within Pfizer. ⚬ Facilitated African and Middle Eastern markets by publishing submissions, utilising ISI Publisher. ⚬ Utilised Business Objects and Liquent Insight to run and compile Annual/Product Quality Review, accomplished 100% compliance with APQR’s for 2017. Use of Liquent Insight publishing system, GDMS document management system, Business Objects and Microsoft Sharepoint.

AbbVieRegulatory Submissions Specialist

Jun. 2015 - May. 2017MaidenheadEngaged to coordinate submission of filings to regulatory agencies across EMEA. Oversaw the pre-publishing and post-publishing phases of regulatory submission and supported selection of cost-effective outsourced publishers to complete tasks to deadlines. ⚬ Played a key role in ensuring maximum compliance to obtain affiliations from certified organisations and regulatory bodies, including Certificate of Pharmaceutical Product, Certificate of Good Manufacturing Practice and Letter of Authorisation. ⚬ Participated in major initial MAA for European Centralized Procedure for Mayyret, resulting in no objection received from CHMP during validation period Regional Submission Specialist. Pre-Publishing tasks and M1 planning using eCTD express, Lorenze Docubridge, Microsoft Sharepoint and eDocs. Europe, Middle East and Asia. Brief exposure to CTA’s.

RBRegulatory Affairs Associate

Apr. 2013 - Jun. 2015Hull, United KingdomRecruited to publish (using Liquent Insight) and submit variations with respect to specific Lemsip, Strepsils formulations. Compiled and published dossier sections for ROW countries.

RBAnalytical Associate Research and Development

Apr. 2011 - Mar. 2013Recruited as part of geographical-expansion team to perform routine stability testing of existing and new Nurofen formulations. Analysed properties of Nurofen formulations using reverse grade HPLC and physical chemistry testing.