Sheila Bello Irizarry
Principal Consultant, Regulatory Affairs Strategy @Opus Regulatory Inc.
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WORK HISTORY
Principal Consultant, Regulatory Affairs Strategy @Opus Regulatory Inc.
EDUCATION
University of Rochester School of Medicine and Dentistry
Doctor of Philosophy (PhD), Microbiology and Immunology
University of Rochester
Master of Science (M.S.), Microbiology and Immunology
University of Puerto Rico-Mayaguez
Bachelor of Science (B.S.), Industrial Biotechnology
SKILLS
ABOUT SHEILA BELLO IRIZARRY
Highly motivated leader and regulatory strategist with more than 20 years of experience in clinical and nonclinical research and drug/vaccine development.• Significant experience in leading early and late-stage regulatory drug/vaccine development programs and major regulatory submissions, including INDs/CTAs, Emergency Use Authorizations (EUAs) and full marketing authorizations (BLA/NDA, MAAs), among others.• Experienced in leading cross functional teams in major regulatory submissions, health authority interactions and expedited regulatory designations and pathways, such as orphan drug designation, fast track designation, breakthrough therapy designation requests, accelerated approval pathway• Proven successful leadership and project management experience• Ability to work strategically within business-critical and high-profile development programs• Extensive knowledge of regulatory procedures and legislation for drug development, product registration, and line extensions.• Diverse therapeutic area experience: biologics, drugs, immunology, infectious diseases, vaccine development, monoclonal antibodies (mAbs), inflammation, neuromuscular disorders, rheumatology, neurology, CNS, rare diseases, oncology, lung biology, gastroenterology, dermatology, hormone replacement therapy, analgesia
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