Zak Huang

Visionary regulatory executive leading global strategies and organizational transformation across transplant, autoimmune, and gene therapy programs. Recognized for delivering innovative, science-driven solutions that advance both regulatory excellence and business value. ✦ Transformed the organization into a center of excellence, fostering a trusted regulatory function that is now seen as a catalyst for impact and a reliable business partner. Shaped strategic decision-making through influential collaboration and scientific insight, driving forward a culture of innovation and agility. ✦ Led development and execution of integrated regulatory strategies, aligning with business objectives and enhancing patient access across global markets. Instituted cross-functional strategy initiatives, including a 4-month cross-functional workshop that resulted in a compelling comprehensive storyboard and expanded proposed indication for the company’s first US marketing application—strengthening regulatory positioning and access strategy. Drove operational excellence in regulatory planning and execution, including CTAs, regulatory agency interactions, and MAA preparations, resulting in accelerated development timelines and optimized submissions. ✦ Proactively engaged with global health authorities across Phases 1–3, shaping agency thinking on key development, registration, and access issues. ✦ Established a high-performing, empowered regulatory team, emphasizing shared purpose, mentorship, and meaningful career growth—creating a culture where professionals feel supported, valued, and proud. Recruited and developed top-tier regulatory talent, embedding leadership excellence and future readiness within the team.

Led global regulatory function, spearheading regulatory strategy development and execution to support company’s portfolio globally.

Established and led multi-functional comprehensive R&D organization for new product development programs in China for global $150B biopharmaceutical company. Managed business unit with ~30 staff, including regulatory affairs, project management, R&D quality assurance, clinical operations, product safety and pharmacovigilance, manufacturing process development, analytical development, technology transfer, and virial safety.

Hired as cardiovascular therapeutic head; promoted in 6 months to lead 5 therapeutic areas. Created and implemented science-based, solution-oriented, and globally aligned regulatory strategies for new product development and life-cycle management, in cardiovascular, pulmonary, immunology and autoimmune, hematology, transplant, and rare diseases.

Led global regulatory teams in development and execution of global regulatory strategy for pharmaceutical, biologic / biosimilar, medical device, and combination products. Therapeutic Areas: diabetes, cardiovascular, pulmonary, arthritis, oncology, women’s health, infectious diseases, and rare diseases.

Led development of regulatory strategy for multiple Class II and III medical device products.

Designed and conducted Phase I and II cardiovascular clinical studies.

Designed and conducted clinical trials of Class III cardiac rhythm management devices.