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Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM

Director, Regulatory Submission Planning
Biogen

Cassandra San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM, Director of Regulatory Submission Planning, is a certified project manager with an extensive pharmaceutical industry career in regulatory affairs, product development, clinical trial management, diagnostics R&D, resource management, and portfolio management. Her expertise is across multiple therapeutic areas and all phases of drug development. She earned her Master's in RA/QA from Temple University and has held her RAC since 2016. She started her career as a scientist at Roche Diagnostics where she focused on assay development. She moved into project management at Merck & Co and then Janssen Pharmaceuticals. She has been collaborating directly with global regulatory teams in support of major and life-cycle regulatory submissions since 2014; first at Janssen Pharmaceuticals (2014-2021), and now at Biogen (2021-Present), where she is currently the head of the Regulatory Submission Planning team within the Submission Sciences - Global Safety & Regulatory Sciences (GSRS) department.

Disclosure information not submitted.

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