Kishor Karande

Experience

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  RAPTAKOS BRETT & CO.

  Feb 2005 - Jul 2007

  Executive Regulatory Affairs

  All Regulatory Submissions, Variations, Renewals, CMC Writing, Dossier Collation, Labeling Submissions, Response to Question, Compliance assessment, Gap Analysis, Licencing

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  Montajat Pharmaceuticals Co., Ltd.

  Aug 2007 - Jun 2009

  Assistant Manager- Regulatory Affairs

  All Regulatory Submissions, Lifecycle Management, eCTD and NeeS publishing, CMC Writing, NTA to CTD conversion, Response to Question, Team Building, Compliance assessment, Gap Analysis, Training and Management.

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  Pharmalink Consulting

  Jun 2009 - Mar 2013

  Senior Regulatory Affairs Executive

  I have extensive experience in Regulated, semi regulated and non-regulated markets. I am good in communicating and negotiating with Regulatory agencies, ensuring fast Preparation of dossiers, efficient approval of renewals, variations and change of ownership for pharmaceutical products in especially in UK, EU, South Africa, Sub Saharan Africa, APAC, MENA, Latin America, CIS Countries. This has enabled his clients to achieve considerable cost & time savings. I am very effective in coordination with all concerned parties, meeting and surpassing deadlines. I have demonstrative ability to perform multiple projects simultaneously. I can successfully organize and prioritize work assignments and projects and would like to work with moderate supervision. I am very well expert in the use of Microsoft Office Suite (i.e., MS Word, Excel, PowerPoint, Adobe Acrobat); Proficient in electronic regulatory submissions and document management. I have great ability to meet worldwide tight target dates in a pressured environment. Show less

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  ADVANZ PHARMA

  Mar 2013 - now

  Regulatory Manager