Ayelet Salemon

Experience

• 

  Teva Pharmaceuticals

  Feb 2007 - Oct 2009

  Process Validation Engineer

  Project Manager of scale-up process from the R&D phase to the mass production phase. Following the GMP guidelines, preparing the submission files for the FDA

• 

  Ludan Group

  Mar 2012 - Sept 2016

  Validation Engineer

  Validation engineer providing multidisciplinary support in QA and validation procedures for utilities, equipment and process.

• 

  UroGen Pharma

  Oct 2016 - now

  Project manager for R&D projects, team & operation cross-departments.Project manager for CMC activities to support IND & NDA submissions and Devices 510(K) submissions.Leading human factor validation studies. Manage all development activities of existing & new Medical Devices to support clinical studies and regulatory submissions.

  • Director Project Management & Operations, RA

    Aug 2018 - now

  • Projects Manager

    Oct 2016 - Aug 2018