Jim Wang

About Jim Wang

Strategic and results-driven senior executive with over 20 years of US and global regulatory experience. • Proven track record in leading global submissions and approvals for pioneering therapies, including LUXTURNA,(the first FDA-approved gene therapy for a genetic disease), UPSTAZA,(the first gene therapy infused directly into the brain), and SAXENDA (the first GLP-1 agonist approved for weight management). • Visionary leader with a strong record of building and mentoring high-performing global regulatory teams in both smaller biotech and large organizations.• Broad expertise in developing biologics, gene therapies, and drug-device combination products across multiple therapeutic areas, including ophthalmology, CNS, metabolic, endocrine, cardiovascular, and women’s health; Successfully brought to market LUXTURNA, UPSTAZA, SAXENDA, ELIQUIS, MULTAQ, FARXIGA, and DUAVEE.

Experience

1. Vice President Regulatory Affairs

   Regeneron

   Aug 2023 — Present · US

   Leading a global regulatory strategy team responsible for the development and approval of products across the genetic medicines (gene editing/insertion, silencing, and AAV), thrombosis, and obesity portfolios.

Education

• Penn State University

  Master of Business Administration - MBA

• University of Illinois Urbana-Champaign

  Doctor of Philosophy - PhD, Chemistry

Skills

• Cmc
• Regulatory Affairs
• Pharmaceutical Industry
• Fda
• New Drug Application (Nda)
• Therapeutic Areas
• Ectd
• Regulatory Requirements
• Ind
• Clinical Trials
• Clinical Development
• Biologics
• Protocol
• Nda
• Biotechnology
• Drug Discovery
• U.s. Food and Drug Administration (Fda)
• Regulatory Submissions
• Drug Development