Umar Khan

Experience

• 

  Hetero

  Aug 2018 - Jan 2019

  Internship - Regulatory Affairs

  • Focused on Regulatory Affairs within the Formulation Department for the Middle East region, particularly the Gulf Cooperation Council (GCC) countries.• Prepared dossiers in compliance with Health Authority regulations.• Successfully completed a project on 'Regulatory Requirements for eCTD Dossiers for GCC Submissions'.

• 

  Navitas Life Sciences

  Apr 2019 - now

  • Specialize in overseeing the publication of dossiers across various formats (eCTD, eSub, and paper), ensuring 100% accuracy through rigorous quality control.• Mentor new team members and facilitate training and demo sessions on submission tools.• Serve as a subject matter expert (SME) in eCTD submissions, providing valuable insights and guidance to enhance team performance.• Conduct detailed quality checks to maintain high standards in submission accuracy and compliance.• Lead initiatives to improve processes and tools for more efficient dossier management and publishing. Show less

  • Senior Regulatory Associate I

    Apr 2024 - now

  • Regulatory Associate

    Apr 2022 - Mar 2024

  • Junior Regulatory Associate

    Apr 2021 - Mar 2022

  • Regulatory Associate Trainee

    Apr 2019 - Mar 2021