Rachael Steiner Swiat
VP & Global Head of Regulatory Affairs, Oncology & Hematology @Novartis
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WORK HISTORY
VP & Global Head of Regulatory Affairs, Oncology & Hematology @Novartis
EDUCATION
Fairleigh Dickinson University
MBA, Pharmaceutical Management
Seton Hall University
M.Sc., Biology
Lafayette College
B.S., Biochemistry
SKILLS
ABOUT RACHAEL STEINER SWIAT
Highlights:• Over 25 years industry experience, all in regulatory affairs, functioning in a global strategy role, including US, Europe, Canada & Japan, including 15+ years people management experience. • Regulatory experience with biologics and drugs across oncology, hematology, respiratory, dermatology, endocrinology, neurology, immunology, rheumatology, muscle atrophy/wasting, Human Immunodeficiency Virus (HIV) & Hepatitis B&C Infection indications.• Extensive experiences in specialty product development for orphan indications with utilization of orphan product registration (US, EU, Japan, Switzerland), break-through therapy, fast track and accelerated assessment strategies.• Current managerial experience of direct reports both co-located and abroad as well as interns; matrix oversight in role as group head.
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