Yogesh Shenvi

Group Manager Regulatory Affairs at Avacare Health Group
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN

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Credentials

  • Foundations in Biosimilars
    Medicines Control Authority Of Zimbabwe
    Apr, 2022
    - Nov, 2024
  • Certificate Course in Drug Regulatory Affairs (DRA)
    Udemy
    Jan, 2022
    - Nov, 2024

Experience

  • Avacare Health Group
    • South Africa
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Group Manager Regulatory Affairs
      • Apr 2017 - Present

      • Responsible for Life cycle management of the products. • Preparing regulatory submission strategies, conducting dossier due diligence and timely submission of marketing authorisation regulatory applications to the authorities in SADC region, ASEAN countries & EAST AFRICAN Countries.• Ensuring quality & timely preparation/submission of dossiers according to plans and agreed timelines. • Providing support and guidance to the business development team & tender team when evaluating new projects.• Involved in on site physical GMP inspections by authorities. • Reporting on regulatory progress and issues for new products at all project team and project review meetings, and to senior management as required.• Providing training & publishing documents for eCTD & NeeS submissions.• Acquiring and maintaining current knowledge of applicable regulatory requirements and scientific/technical issues and discipline as relevant to assigned projects. Show less

    • Regulatory Affairs Executive
      • Jun 2015 - Mar 2017

      • Marketing Authorisation Application submissions to French West African countries.• Participated in tender business for French West African countries for pharmaceutical products & medical devices.• Tenders awarded in CAME Benin, CAMEG Burkina Faso, SALAMA Madagascar, CPA Chad, NPSP Ivory Coast and Swaziland.

  • M/s. Plethico Pharmaceuticals Ltd.,
    • Mumbai
    • Regulatory Affairs Executive
      • Jan 2011 - Jun 2015

      • Marketing Authorisation Application submissions to ASEAN, CIS and AFRICA region with Regulatory compliance. • MAA submissions for complementary products for European & CIS region for a subsidiary Natrol, Inc., USA. • Acquiring and maintaining current knowledge of applicable regulatory requirements and scientific/technical issues and discipline as relevant to assigned projects. • Keeping a close watch on emerging new regulations in the region and lobbying when needed with relevant authorities. Show less

  • Cipla
    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Management Staff Regulatory Affairs
      • Dec 2009 - Dec 2010

      • Marketing Authorisation Application submissions to TGA, Australia and USFDA (Veterinary) • Technical Agreements. • Product Management System (PMS). • Marketing Authorisation Application submissions to TGA, Australia and USFDA (Veterinary) • Technical Agreements. • Product Management System (PMS).

  • S Kant Healthcare Ltd.
    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Associate
      • Dec 2008 - Nov 2009

      • Marketing Authorisation Application submissions to emerging markets. • Participated & awarded in various African tenders. • Packaging material supplier audits • Marketing Authorisation Application submissions to emerging markets. • Participated & awarded in various African tenders. • Packaging material supplier audits

Education

  • University of Mumbai
    Master of Business Administration - MBA, Marketing
    2011 - 2014
  • Sophia College, Mumbai
    Post Gratuate Diploma in Quality Assurance
    2007 - 2008
  • University of Mumbai
    Bachelor of Science (Chemistry)
    2003 - 2006

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