For more than 25 years, Dr. Yogita Desai has led the development, approval, and market introduction of groundbreaking therapeutics in the pharmaceutical sector in the United States. Dr. Desai received her B.S. degree in Pharmacy from St. John’s University, NY and her Ph.D. degree in Pharmaceutical Sciences from the University of Rhode Island, RI. Dr. Desai’s professional journey began as a Product Development Scientist, progressing steadily through various roles of increasing responsibility within Regulatory Affairs and Compliance. Most recently, Dr. Desai served as the Director of Regulatory Strategy and Global Regulatory Affairs at Pfizer, Inc. for 8 years. Dr. Desai’s expertise lies in crafting and executing comprehensive regulatory strategies crucial for the approval and commercialization of innovative products.

Dr. Desai possess extensive hands-on experience in preparing and submitting INDs/NDAs and overseeing their life cycle management for diverse drug molecules and dosage forms, addressing a broad spectrum of medical conditions in patients globally. She has contributed significantly to over 50 INDs and 25 NDAs. She was instrumental in approval of Tobramycin/Dexamethasone eye drops (ANDA #217584) and Ciprofloxacin eye drops (ANDA# 076555), and systemic antibiotics (e.g., Ceftaroline fosamil against MRSA; NDA#200327).

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