Ms Susan Hensley | Senior Director, Regular Operations, Compliance And Regular Affairs

Ms Susan Hensley, Senior Director, Regular Operations, Compliance And Regular Affairs, Takeda

Susan joined Takeda’s Vaccine Business Unit Regulatory Affairs group in June of 2019 where she leads and oversees the Regulatory Operations team. Prior to joining Takeda, Susan spent approximately 5 years at Novavax, Inc as the Head of Regulatory Operations. Her time at Novavax was preceded by Human Genome Sciences, where she led the successful filing of 3 BLAs in 2 years. Prior to joining Human Genome Sciences, Susan spent 10 years in various roles within Regulatory Affairs at Otsuka, Nabi, and Shire where she worked on numerous global marketing applications. Susan holds a RA certification through RAPs, a BA degree in Social Work and Psychology from University of Maryland Baltimore County, a Master’s degree in Clinical Social Work from University of Maryland at Baltimore, and is currently enrolled in the Master’s of Regulatory Science program at Johns Hopkins University.


Day 2, April 8 @ 12:10

Can we achieve global harmonization of regulatory requirements for vaccines

  • Managing regulatory requirements and timelines while rolling out vaccine globally
  • Variability of assays and tests required internationally
  • Practicalities are very challenging – how do big pharma manage this?
  • Insurance of process control – what will satisfy regulatory bodies downstream?
  • When and how should you engage with regulatory bodies
last published: 05/Mar/20 10:35 GMT

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