Cindy Cao

Senior Vice President, Head of Regulatory Affairs

Bridgewater Township, NJ

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About

• Experienced pharmaceutical and biotech executive leader with twenty years of proven track record in R & D. Extensive progressing experience in global and US regulatory affairs as Project Lead, FDA Contact and Department Head • Strong regulatory strategist experienced in establishing global regulatory plan and providing guidance to drug development and executive team • Rich regulatory knowledge and experience with clinical, nonclinical, CMC and labeling aspects of global development programs as well as marketed products; first-hand experience with device, combination product and biosimilars • Highly skilled in leading meetings and negotiating with health authorities including FDA and EMA. First hand experience with different divisions CDER, CBER and CDRH of FDA; Solid working experience with filing small molecules and biologics IND/CTA/NDA/BLA/510K . Experience in establishing and overseeing quality management system and GCP focused QA • Extensive experience in working on regulatory policies across-functionally and interfacing with trade associations • Strong scientific background in metabolic/cardiovascular diseases, immunology, oncology, gastroenterology, and hematology • Twenty plus years of line and cross-functional supervising experience as Program Lead, Platform Leader and Department Head

Work experience
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Jun 2018 - Present

Ascentage Pharma

Senior Vice President, Head of Regulatory Affairs

• Oversee regulatory affairs and quality assurance department, responsible for multiple oncology development projects • Develop global regulatory strategy and provide regulatory advice to development team • Lead filing of orphan drug designation, fast track and breakthrough pathway designations, and interactions with global health authorities • Serve as Executive Team member and Paterner Steering Committee member

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Jan 2018 - Jun 2018

Nutrinia

Vice President, Head of Regulatory Affairs

• Serve as the Head of Regulatory Affairs Department; Oversee all interactions with FDA, EMA and global health authorities • Develop global regulatory strategy and company’s submission plan for MAA/BLA on innovative pediatric orphan diseases

Apr 2016 - Dec 2017

Sandoz Inc, a Novartis Company

Executive Director, Head of Regulatory Affairs- Biopharm

• Function as the Head of Regulatory Affairs- Biopharmaceuticals, and manage a team of regulatory affairs professionals to support the biosimilar portfolio development and commercialization • Oversee all interactions and filings with FDA for Novartis/Sandoz biosimilar portfolio

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Apr 2013 - Mar 2016

Bristol-Myers Squibb

Director, Global Regulatory Lead

• Serve as a Global and US Regulatory Lead and regulatory point contact in cross-functional teams • Develop global regulatory strategies and submission plans for projects at Phase 1 through Phase 4 development stages

Jan 2006 - Apr 2013

Novo Nordisk A/S

Project Lead, Regulatory Affairs

• Regulatory Affairs Project Lead for diabetes and hemostasis drug products, devices and combination products • Responsible for filing IND, BLA/NDA and 510K. Experience with both development and marketed products. • Act as company’s point contact with FDA, liason with CDRH, CDER and CBER

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Nov 2001 - Dec 2005

Sanofi

Principal Investigator/Platform Leader

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Jul 1999 - Nov 2001

University of Utah

Assistant Professor

Education

Fudan University

Bachelor of Science (B.S.)

The University of New Mexico

Doctor of Philosophy (Ph.D.)

University of Utah

Post Doctoral Fellow, Oncology, Immunology and Inflammation

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