NIKHIL SHITUT

Manager at V. S. International Pvt.Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN

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Susan Lewis

Nikhil Shitut is is a highly motivated former colleague whom I had the good fortune to work with and follow his careeer. He is always thinking of the next BIG thing. He is a good worker, is well organized and can either follow or lead depending on the task at hand. We often joked that he could start at any position at a pharma company and he would rise to the top quickly. I would highly recommend Nilhil Shitut.

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager
      • Jan 2020 - Present

      Handling worldwide regulatory affairs for drugs, medical devices, biologics. Interaction with local and international regulatory bodies regarding the above tasks.Driving research in complex generics special dosage forms. Bio equivalence and pharmaco kinetics, phase 1 and 3 studies , dossier costing extension, buying selling. Handling worldwide regulatory affairs for drugs, medical devices, biologics. Interaction with local and international regulatory bodies regarding the above tasks.Driving research in complex generics special dosage forms. Bio equivalence and pharmaco kinetics, phase 1 and 3 studies , dossier costing extension, buying selling.

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Manager Indoco Remedies
      • Jun 2017 - Dec 2019

      Global regulatory for generics Global regulatory for generics

    • Spain
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • assistant manager
      • Dec 2014 - Jun 2017

      Working for All markets US, EU, WHO Geneva and ROW regulatory affairs Working for All markets US, EU, WHO Geneva and ROW regulatory affairs

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Asistant Manager
      • Feb 2014 - Dec 2014

      First to file global submission for injectable and Generics First to file global submission for injectable and Generics

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Junior Scientist
      • Jan 2005 - Jul 2006

      Drug metabolism and pharmacokinetics early discovery to late preclinical. Drug metabolism and pharmacokinetics early discovery to late preclinical.

    • Research Associate II
      • 2004 - 2006

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Research Associate
      • Nov 2003 - Dec 2004

      Drug Metabolism and Pharmacokinetics of small molecule compounds. Helped set up the department with the help of team leader. HPLC-LC/MS MS method development and validation. Drug drug interaction studies Drug transport studies Drug Metabolism and Pharmacokinetics of small molecule compounds. Helped set up the department with the help of team leader. HPLC-LC/MS MS method development and validation. Drug drug interaction studies Drug transport studies

    • Chemist
      • Mar 2002 - May 2003

      Process Validation and manufacturing of generic solid dosage formulations. Process Validation and manufacturing of generic solid dosage formulations.

Education

  • North Dakota State University
    MS, Pharmaceutical Sciences
    1999 - 2002
  • University of the pacific
    Pursued PhD, Pharmaceutical Sciences
    2006 - 2008
  • University of Pune
    B.Pharm, Pharmacy
    1994 - 1998

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