Tania G.
Senior Director Regulatory Affairs
About
Regulatory professional with early-development to post-approval clinical and nonclinical regulatory experience across diverse disease areas including hepatology, nephrology, ophthalmology, oncology, psychiatry and inflammatory and orphan diseases with small molecule, monoclonal antibody, polymer and combination device/biologic therapeutics. Additional 8 years conducting research in biopharma industry. Regulatory lead/GRL for early- to late-stage products. sBLA, PAS, (s)NDA [(505(b)(1), 505(b)(2)], MAA, and IND filings. Strategic thinker, planner and developer of regulatory strategies, identifying expedited pathways, lifecycle opportunities, risks, impact, mitigations and probabilities with attention to detail and the big picture. Effective with pre-IPO to large global pharma companies as employee and as co-development partner. Broad life sciences background with PhD in cell biology and MA in biochemistry and molecular biology.
United States
San Francisco
Biotechnology
Regulatory Strategy Development, Biopharmaceuticals, Regulatory Affairs, Clinical Development, Oncology, Clinical Research, Cell, Stem Cells, Biotechnology, Clinical Trials, Combination Products, Medical Devices, Class III Medical Devices, Drug Development, Ophthalmology, Immunology, FDA, Biologics, Strategy, Labeling
Experience
Senior Director Regulatory Affairs
Mirum Pharmaceuticals
San Francisco Bay Area
Senior Director Regulatory Affairs
Tricida, Inc.
San Francisco Bay Area
Director Regulatory Affairs
Tricida, Inc.
San Francisco Bay Area
Director Regulatory Affairs
Pfizer
San Francisco Bay Area
Associate Director Regulatory Affairs
Medivation
San Francisco
Associate Program Director - Product Development Regulatory (Clinical)
Genentech
South San Francisco, CA
Program Manager - Product Development Regulatory (Clinical)
Genentech
South San Francisco, CA
Associate - Clinical Regulatory Affairs
Genentech
South San Francisco, CA
Postdoctoral Research Fellow
Genentech
Investigated human protein kinases required for completion of cellular division
Visiting Instructor
University of California, San Francisco
In addition to teaching, advised students in enrichment programs for inner-city minority students and for first-generation college students
Research Assistant/Associate - antibody engineering
Genentech
Education
University of California, San Francisco
Biochemistry and Cell Biology
Tania G.'s Contact Information
Phone
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