Prashanth Narwade

Experience

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  Wockhardt

  Jul 2009 - Mar 2010

  Packing Officer

  Roles:• Handled packing activities as per scheduled plans and monitored the quality and productivity of products at all stages of Packing (Blister, Bottle, Injections and Cold Wallet Sealing )• Reviewed and documented batch packing record and sequential log• Managed manpower during each shift working• Monitored and maintained calibration reports of equipments, supported the QA team during qualifying the equipment’s and pack line validation

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  Leben laboratories pvt. ltd.

  Jun 2010 - Jan 2011

  Quality assurance officer

  Key Role:Accountable for carrying out all shop floor activities including in-process checks and line clearance at all stages of Manufacturing and Packing for solid, liquids, ointments & powder formulationsReview:Technical Documents including Master Batch Manufacturing Record, Master Packing Record, Annual Product Review, Vendor Audit ReportsMaintained:• Packing Material Specifications• Certificate of analysis report for packing material• Material Receipt Voucher Show less

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  Cipla

  Jan 2011 - Dec 2013

  Senior Quality Assurance Officer

  Key Roles:• Investigating by using risk management tool (Failure Mode and Effective Analysis)• Handling Of Change Control And DeviationPreparing and maintaining of:• Annual Product Quality and Product Performance Review• Manufacturing review of Out Of Specification and Out Of Trends• Pack line validation protocol and reportMonitoring:• Batch Manufacturing and Packing Record• Sequential Log for Store, Manufacturing and Packing Departments• Vendor Reports for raw & packing materials• Supervising in approving the dispatch through batch release system• Examining the IPQC checks and online documentation in manufacturing & packing Show less

• 

  Eisai Pharmaceuticals

  Jan 2014 - Apr 2015

  Executive-Regulatory Affairs

  Key Roles:•Preparation of Dossier & Registration of New Drug Application Imported from regulated countries like Japan, Europe, USA, Italy for manufacturing, marketing, distribution & initiating clinical trials in India.•Application and approval of Test license form DCGI involved in clearance of CDTL testing and custom clearing of imported drug.•Preparation of Dossier and Registration of Medical devices imported form regulated market.•Renewal application of Import license, registration of manufacturing site and repacking permission.•Query responses for post DMF Submission queries, NDAC queries.•Application for filling change variation with respect to ownership change, drug substance, drug product. •Serious adverse event reporting to DCGIReview of:•Clinical trial protocol as per Indian regulations•Periodic safety updates reports.•Informed consent document.• ICF Translations and their Back translation in various languages.•Master documents involving Drug master file for drug substance and drug product.•Application of registration of contract manufacturing, wholesale license premises from local FDAQuality AssuranceReview of :•Specification, standard testing procedure & COA of API and finished formulation•Stability study reports, Annual product review, validation record•Artworks for New drugs as per Indian regulations•Performing quality audits of contract manufacturer and suppliers•Change control, deviation, OOS, OOT Show less

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  Roche

  May 2015 - May 2021

  Supporting and Obtained favorable outcome through SEC meetings for timely launch of sNDA and line extension Working on registration projects to obtain most rapid & optimal registrations of new products and all variations including manufacturing site change, indication change etc.Provide regulatory expertise and input into cross-functional Affiliate business strategiesLiaise proactively with the internal functions and external partners and lead cross-functional delivery teams for complex submissions, providing expert regulatory adviceMonitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product maintenance/ divestment/ withdrawal program Show less Key Roles:-Timely launch of new drugs and line extensions (NDA & sNDA):Ensure file readiness per agreed timelines for timely submission-Maintenance of regulatory licences:1.Renewal applications (RC, IL and Test license) and ensure file readiness for timely submission.2. Provide Regulatory documentation support for achieving targeted growth from Institutional Business3. Application of registration of contract manufacturing, wholesale license premises from local FDA- Preparation of strategy and plan submission of change variations to HA as per standard timelines and prescribed in guidelines- Preparation of strategy and plan submission of query responses reaised during NDA, sNDA and Clinical Trial applications- Online submision of applications related to Registration of Manufacturing sites and Import license- Preparation and compilation of documents related to Clinical Trial applications (Global and Domestic studies).- Managing registration projects to obtain the most rapid and optimal registrations of new products, manufacturing site changes and all variation including maintenance of existing products.- Ensures the regulatory compliance to regulation as well as directive of regulatory affairs and relevant regulation.- Building and cultivating important working relationships internally and externally.- Assists in the review of product labeling to ensure compliance with HA regulations.- Assists in the preparation of international registration dossiers for use in internationalregistrations. Show less

  • Assistant Manager

    Oct 2018 - May 2021

  • Regulatory Affairs Executive

    May 2015 - May 2021
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  Novo Nordisk

  May 2021 - May 2024

  • Senior Regulatory Affairs Project Manager

    Oct 2023 - May 2024

  • Senior Regulatory Professional

    May 2021 - Oct 2023
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  AbbVie

  May 2024 - now

  Senior Manager Regulatory Affairs