Qi Cheng

About Qi Cheng

Extensive experience in global regulatory affairs with a proven track record of leading IND, CTA, and NDA preparations and submissions, as well as managing comprehensive regulatory strategies across multiple programs. Skilled in authoring high-quality regulatory documents and leading successful interactions with global health authorities, including FDA and EMA.Thorough understanding of FDA and EMA regulations, ICH guidelines, and GCP/GLP compliance. Strong foundation in clinical trial execution, data management, biostatistics, and the overall drug development lifecycle.Therapeutic expertise includes oncology, CNS, rare diseases, and other areas. Additional experience in regulatory writing, clinical operations, and cross-functional collaboration to drive regulatory and development milestones.

Experience

1. Director Global Regulatory Affairs

   Takeda

   Sep 2022 — Present

   Lead regulatory activities of CNS projects towards NDA, BLA and MAA filings; define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Lead regulatory activities of early phase ADC program.Provide strategic and tactical guidance to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.Act as a direct contact with the FDA; lead HA meetings/discussions and preparation of response to global HA queries; oversee US submissions; review and approve global submissions.Work on due diligence programs, review confident information and assess feasibility, potential and risk.Oversee vendor responsibilities for regulatory activities and submissions

Education

• Shenyang Pharmaceutical University

  BS, Pharmaceutical Chemistry

  1991 — 1995

• Peking Union Medical College

  Master, Pharmacology

  1995 — 1998

• Rutgers Robert Wood Johnson Medical School

  M.S, Clinical & Translational Science

  2009 — 2011

• University of South Carolina School of Medicine

  Ph.D, Physiology/Pharmacology

  2000 — 2004

Skills

• Pharmacology
• Neuroscience
• Clinical Research
• Clinical Trials
• Medical Writing
• Drug Development
• Fda
• Clinical Development
• Regulatory Affairs
• Molecular Biology
• In Vitro
• Lifesciences
• Drug Discovery
• Cancer
• Biotechnology
• Scientific Writing
• Clinical Study Design
• Ind
• Oncology
• Immunology
• Infectious Diseases
• Cancer Research
• Cell Biology
• Science
• Life Sciences
• U.s. Food and Drug Administration (Fda)
• Project Management