Debashish Sarkar

Experience

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  Parul Group of Institutes

  Feb 2013 - Mar 2013

  Student Coordinator

  Managed around 1500 participants from all over India at Pharmafest-2013.Hosted Pharmafest 2013.Handled the all-round work for at the same .

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  NIRMA University

  Jul 2014 - Jun 2016

  Student of Master of Pharmacy- Regulatory Affairs and Quality Assurance
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  Alkem Laboratories Ltd.

  Jul 2015 - Jun 2020

  Develop and execute regulatory product filing strategies for Australia and Europe Market.Complete handling of regulatory activities for Third Party business in Australia.Liaise with competent authorities to seek advice and guidance as and when required.Ensure RMP’s as per current GVP guidelines for Europe and AustraliaCo-ordination with cross-functional teams (Business team & Pharmacovigilance team, Third party regulatory professionals)Providing training to cross functional teams on regulatory guidelines. Show less Work Area- Europe and Australia Market.Preparation and assist in submission of marketing authorization applications for Australia and Europe.Handling of regulatory activities for third party products in Australia.Review labelling, product information and ensure compliance.Review of quality documents for submission to regulatory authority.Performing gap analysis and finalizing strategies for variation submission to regulatory agencies.Compilation and validation of complete eCTD dossier (Module 1 to Module 5).Ensure PDF properties as per eCTD requirements.Submission of variations to maintain life cycle management of products in Australia and Europe.Maintenance of product list online giving 24 hours access of product information for multiple uses.Insert, update and maintain XEVMPD database of products registered in Europe.Ensure RMP’s as per current GVP guidelines for Europe and Australia. Show less

  • Scientist

    Apr 2019 - Jun 2020

  • Research Associate

    Mar 2017 - Mar 2019

  • Trainee Research Associate- Drug Regulatory Affairs

    Mar 2016 - Mar 2017

  • Project Trainee

    Jul 2015 - Mar 2016
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  Pharmacor Pty Ltd

  Mar 2017 - Jun 2020

  Regulatory Affairs Associate

  Providing regulatory support for product submissions, life cycle management, Third Party product registrations, finalization of technical agreements, providing training, etc.

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  ADVANZ PHARMA

  Jun 2020 - Nov 2021

  Regulatory Affairs Executive
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  Cipla

  Dec 2021 - now

  Deputy Manager - Regulatory Affairs

  Responsible for developing and overseeing implementation of regulatory strategies and making decisions to ensure high quality regulatory submissions.Performing assessment of CMC changes, identifying regulatory requirements, evaluating supporting documentation and provide inputs on regulatory filing strategies.Providing regulatory oversight on change control impact assessment, discrepancy management and regulatory conformance on registered products.Execute regulatory strategies by leading the development, authoring and review of regulatory submission documentation to support variations and other post approval activities.Review of labelling, product information to ensure compliance.Manage cross functional team members to ensure quality, content and format of regulatory submissions to comply with applicable regulations and guidelines.Performing gap analysis and finalizing strategies for variation submission to regulatory agenciesCritically monitoring launch gap analysis of products to ensure successful launch of product in the market.Handling of renewal submissions, MA transfers, MA withdrawal, sunset clause exemptions, and other activities as and when required for registered products.Collaborate with global stake holders to align on product filing priorities and post approval activities for continued availability of products.Assess and communicate potential regulatory risks and propose mitigation strategies.Responsible for delivery of assigned milestones for all products across product lifecycle. Show less