Sunita Sethi

Senior Vice President, Regulatory @ Tenaya Therapeutics arrow icon

Sunita Sethi's Title

Sunita Sethi currently holds the esteemed position of Senior Vice President, Regulatory. With an extensive career spanning over three decades, she has established herself as a leading figure in the regulatory space, guiding pharmaceutical companies through complex regulatory landscapes and ensuring compliance with global health authorities. Her title reflects a high level of responsibility and expertise in overseeing regulatory affairs, which is crucial for the successful approval and monitoring of pharmaceutical products.

Sunita Sethi's Education and Expertise

Sunita Sethi is well-equipped with a solid educational foundation, holding a Pharm.D. from the University of South Carolina and a B.S. from Rutgers University. These academic credentials have provided her with a deep understanding of pharmaceutical sciences and regulatory requirements. Her expertise is further amplified by her diverse experience in regulatory, medical affairs, clinical research, and pharmacovigilance, making her a versatile and highly knowledgeable professional in the industry.

Sunita Sethi's Background

Sunita Sethi has accumulated over 30 years of industry experience, holding leadership roles across several high-profile pharmaceutical companies including Astra Zeneca, Pharmacyclics, J&J, and Elan Pharmaceuticals. Her background showcases a broad spectrum of responsibilities, from regulatory affairs to clinical research and pharmacovigilance. This extensive experience has allowed her to develop a comprehensive understanding of the pharmaceutical development lifecycle and the regulatory challenges that accompany it.

Sunita Sethi's Achievements

One of Sunita Sethi's most notable achievements was her recent role as Senior Vice President, Head of Global Regulatory Affairs at ChemoCentryx, where she led efforts to secure the company's first FDA approval for an orphan indication. This milestone is a testament to her regulatory acumen and strategic foresight. Additionally, her tenure as Senior Vice President, Global Regulatory Affairs with Everest Regulatory Services highlights her influence in shaping regulatory policy at a global think tank, further underscoring her impact on the industry.

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