Jay Bordoloi
Regulatory Senior Program Director @Genentech
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WORK HISTORY
Regulatory Senior Program Director @Genentech
South San Francisco, CA, US
EDUCATION
Rutgers University
Doctor of Pharmacy (Pharm.D.), Pharmacy
ABOUT JAY BORDOLOI
Developed global regulatory strategies and contributed to clinical development plan decision-making across early- and late-stage development (small+large molecule) programs as Global Regulatory Lead or US Regulatory Lead. Expanded my clinical study design and study management knowledge during a clinical science rotation (Product Development Clinical Science). Contributed to new protocol authoring, proposed new protocol study design ideas, and conducted data review for ongoing studies.Experienced with leading US/EU health authority interactions and leading Investigational New Drug/Clinical Trial Application filing teams. In addition, I have led US regulatory strategy and associated trial management/marketing application filing activities for a biologic product from end-of-phase 2 through to product approval.
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