Jim Wang, Phd, Mba Email & Phone Number

Tarrytown, New York, US

Leading the global regulatory strategy team focused on the development and regulatory approval of genetic medicines.

Redwood City, California, US

Redwood City, California, US

Redwood City, California, US

US

Served as the global product leader and oversaw the strategy implementation and operation of cross-functional teams for the manufacturing, regulatory submission, and commercialization of a gene therapy product (UPSTAZA) that treats patients with Aromatic L-Amino Acid Decarboxylase deficiency. It received EU approval in July 2022.

Philadelphia, PA, US

Led BLA, MAA submission and approval for Luxturna, first gene therapy approved by both FDA and EMA that treats patients with a genetic disease: led pre-submission meetings with the Agency and development of product labeling, risk management plans, and submission documents; managed agency interactions during product review, FDA Adcom, EMA scientific.

Bagsværd, DK

• Led a global regulatory team and managed the simultaneous submission and approval for SAXENDA® (liraglutide 3 mg) in US, EU, and Canada.
• Managed a headquarters regulatory team in Denmark by mentoring staff on development of therapeutic knowledge, setting performance goals, and conducting appraisals.
• Led Agency interactions with FDA, EMA, PMDA, COFEPRIS, Health Canada, and China FDA.
• Developed proactive global regulatory strategy for key markets as outlined in the product development plan.
• Chaired a multi-disciplinary rapid response team by providing strategic inputs to draft and finalize Agency responses.

Lawrence Township, NJ, US

Served as a Global Regulatory Team Leader and FDA liaison for development of cardiovascular and metabolic products. Represented regulatory in global development teams. Developed global regulatory strategy, target labeling, and global submission plans. Provided strategic inputs to clinical and commercial to ensure alignment of product development and market.

Paris, France, FR

Served as a liaison with FDA division of cellular and gene therapy, cardio-renal, and neurology products. Led Agency meetings (pre-IND, end-of-phase I and II, pre-NDA, pre-BLA, and FDA advisory committee meetings). Global regulatory lead for a late stage gene therapy product: End of phase II meeting, phase III special protocol assessment, global CTA.

New York, New York, US

Regulatory representative in Wyeth global development and technology teams. Supported NDA submission and approval of DUAVEE®. Interfaced directly with FDA for assigned products by conducting formal meetings and reviewing regulatory submissions. Developed CMC content for CTA, marketing applications, and registration of manufacturing changes.

New York, New York, US

DMPK team representative in multi-disciplinary discovery teams. Provided drug metabolism and pharmacokinetics expertise to aid drug candidates selection/optimization. Conducted research to characterize reactive and toxic metabolites of drugs and published an invited book chapter in “Integrated Strategies for Drug Discovery Using Mass Spectrometry” by John.

Doctor Of Philosophy - Phd, Chemistry

Master Of Business Administration - Mba