Arun Mishra

Experience

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  Indian Pharmacopoeia Commission

  Jun 2006 - Jul 2006

  Project Summer Trainee(CIPL)
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  Panacea Biotec

  Jun 2007 - Jul 2007

  Project Trainee- Quality Control

  Testing of Non-Parenteral Formulation And Raw Material by Microbiological Methods

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  Central Drugs Standard Control Organization

  Jul 2008 - Jun 2011

  Technical Data Associate

  Review and evaluation application of NDA/sNDA & CTA for Vaccines & Biological and IVD including Clinical Trial Protocol, Non-Clinical & Clinical Data, Serious adverse event (SAE)reports, PMS & PSURs. Evaluation of the documentation pertains to Import registration, Manufacturing license as per Indian regulations.Part of WHO project for Institutional development program of National regulatory authority, contributed to process and guidelines development for India Health Authorities (CDSCO) and instrumental in evaluating cross-country regulations and guidelines to harmonize with Indian rules and regulation to strengthen Indian guidelines. Show less

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  Ranbaxy

  Jun 2011 - Nov 2013

  Managed preparation, review, and submission of Product Registration & License and IND/NDA. Review of clinical data, BA/BE Protocol, and preparation of application/dossiers as per Regulatory Guidelines, GCP for BA/BE Study permission from DCGI(CDSCO). Working with the Clinical & Medical team for dossier preparation and review for Clinical Trial & BA/BE study for export, coordinating with R&D for preparation and obtaining regulatory approval and licenses. Liaison with Regulatory Authorities (CDSCO/DCGI/State FDA/CBN/ICMR/ IPC/CDTL). Supported for arrangement of internal audit and inspection of R & D facility.Facilitated Project Lifecycle Management team by contributing inputs on regulatory process to ensure effective and timely approvals and commercialization of products. Regulatory consultation to R&D, Manufacturing plants, Clinical PK/PD department and global regulatory team. Show less

  • Manager- Regulatory Affairs

    Jul 2013 - Nov 2013

  • Sr. Executive-Regulatory Affairs

    Jun 2011 - Jun 2013
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  Centrient Pharmaceuticals

  Nov 2013 - Jun 2016

  Manager-Regulatory Affairs, Bussiness Unit- Asia Pacific/Middle East/Africa

  Previously know as DSM Sinochem Pharmaceuticals.Managed India & regional Regulatory Affairs function for AMEA, RA lead for the new product portfolio of Sterile API, and Quality assurance & compliance.Prepare, review, submission of dossier/ application for Regulatory Permission registration, Export permission, Manufacturing Licenses, EU-Written Confirmation, COPP, and WHO-GMP.Author & reviewer of Technical dossier (CTD)/ Drugs Master File(DMF), Labeling/ Artwork for registration and variation filling in Asia Pacific/ROW markets.Coordination with the global RA/ QA team for developing the overall strategy and planning for Regulatory submission, query responses, and Global RA updates. Show less

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  LG Life Sciences

  Jun 2016 - Aug 2017

  Senior Manager- Regulatory Affairs & QA

  Managed Regulatory Affairs function including the development of regulatory strategies, submissions, review of the label/artwork, and promotional materials.Interaction & liaisoning with Government authorities (CDSCO/DCGI/State FDA/NPPA).Lead project of RA approval including MA, Registration & licenses with merged entity (LG Life Sciences to LG Chem)Managed preparation and submission of dossier and labeling for product registration, Clinical Trial/ PMS, and variations for Biological, Non-Biological and Medical Devices.Collaborate with Global RA team, Korea for documentation & preparation of regulatory dossiers for India, Sri Lanka & Nepal.Ensure RA, pricing & policy compliances and overall RA activities for CMO products including labeling & artwork. CMO Audits & Due diligence. Show less

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  Astellas Pharma South East & South Asia

  Aug 2017 - Jan 2023

  Lead-Regulatory Affairs(India)

  Leading Regulatory strategies & planning for new product registration(NDA) & indication expansion(sNDA) and clinical trial application(CTA/IND).Leading coordination across regional & global teams (Therapeutic Area Lead, and Global Regulatory lead, CMC, Regulatory Intelligence, CCDS & Labeling, Regulatory Operations, MA, Planning and Administration) forsubmission planning, product registration & import license.Building and maintaining relationships and liaisons with government agencies(DCGI/CDSCO/State FDA/ Govt. labs/NPPA) and pharma associations.Affiliate LT member & extended LT member of SESA region and providing consultations & cross-function support to Sales & marketing, Institutional Business, Supply Chain, and mfg sites; Code of Compliance of promotionalmaterial.Managing local Clinical Trials, leading coordination with CRO for operational & regulatory aspects, and supporting the Global Development team for planning & execution of local CT.Liaison with regional & global Government & Regulatory Affairs stakeholders and regulatory consultation on policy advocacy and managing external GA consultant.Local line manager for PV & QA functions and safety reporting, PSURs, Quality & GDP compliances, and Market Release.Leading coordination with global/regional legal, Corporate communication & commercial team for pricing policy and market access matter and leading communication & coordination with NPPA on DPCO's compliance.Leading implementation and compliance of Global RA system/tools including VEEVA, BLUE, TrackWise(CCTA) and process optimization. Show less

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  アステラス製薬

  Jan 2023 - now

  Global Regulatory Intelligence and Policy responsibilities for primary focus therapy of Oncology and Immuno-Oncology, with a dual regional and global responsibility covering regulatory intelligence and providing strategic analyses/recommendations, managing dissemination of regulatory updates on new/revised legalization and regulatory guidelines and consolidating regulatory trends for the International Region [APAC, MEAR & LATAM] and Greater China region as well as coordinating regulatory policy advocacy activities on a global scale, working on regulatory policy matters related to global regulatory convergence and International Council for Harmonisation(ICH), and global regulatory policy topics. Representing in industry working and expert task groups of global/ regional trade associations. Show less

  • Associate Director-Global Regulatory Intelligence and Policy, PF- Oncology & Immuno-Oncology

    Jan 2024 - now

  • Associate Director- Global Regulatory Intelligence and Policy

    Jan 2023 - Jan 2024
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  Astellas Pharma

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  Associate Director-Global Regulatory Intelligence and Policy, PF- Oncology & Immuno-Oncology