Jody Roth

VP, Global Regulatory Affairs at Immunovant

Jody Roth, RAC, PMP is the Vice President of Global Regulatory Affairs. Most of her career has been focused on autoimmune and oncology therapeutic areas.

Prior to joining Immunovant Ms. Roth held positions with biotech companies as Vice President of Regulatory and Quality as well as COO for several global oncology teams where her leadership resulted in registrations across multiple regions. Jody spent 25 years at Eli Lilly and Company in drug development from discovery to post-marketing phases and across multiple therapeutic areas. She has expertise in global development with emphasis on the US (FDA), EU (EMA), Canada (Health Canada), China and Japan (PMDA). She obtained US approvals for BLAs, and NDAs. She filed multiple INDs and regulatory documents for CTAs to support initiation of new molecules for clinical development.

She is recognized for her communication and advocacy of the label in mind concepts, as well as her expertise in FDA interactions.

Jody obtained her B.S. and M.S. from Purdue University. Her master’s degree was in growth physiology/immunology.

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Timeline

  • VP, Global Regulatory Affairs

    Current role