Rockville, Maryland, United States
As Global Chief Regulatory Officer at Qilu Pharmaceutical, I lead global regulatory strategy to bring innovative and high-quality medicines to patients worldwide. My work focuses on navigating complex regulatory landscapes, aligning cross-functional teams, and accelerating development and approvals across major markets. I bring over 30 years of experience in drug development and regulatory affairs, including a 25-year career at the U.S. Food and Drug Administration (FDA). At the FDA, I led CMC assessments for numerous INDs, BLAs, and NDAs, and directed research programs that helped shape scientific and regulatory standards for biologics and biosimilars. I am passionate about bridging science and regulation to enable efficient development, global access, and sustained product quality. Core Competencies • Global Regulatory Strategy: FDA, EMA, and multi-region development and approval pathways • Scientific Leadership: 100+ publications; 100+ invited presentations; 20+ honors including the FDA Scientific Achievement Award • Mentorship & Talent Development: Mentored 40+ scientists and reviewers advancing into leadership roles • Technical Expertise: Biologics, biosimilars, and CMC development and assessment
Provide executive leadership for global regulatory strategy supporting the development, approval, and commercialization of innovative medicines across major global markets.
Served as a regulatory science leader at the U.S. Food and Drug Administration, advancing the regulatory evaluation, quality assessment, and scientific framework for biologics and biosimilars. • Led CMC regulatory evaluations for IND, BLA, and NDA submissions across multiple therapeutic areas, supporting the development and approval of innovative and high-quality medicines. • Directed multidisciplinary research and cross-functional initiatives advancing the quality, potency assessment, and regulatory science of biologics and biosimilars, while contributing to FDA standards, guidance, and policy development.
Provided regulatory science leadership at the U.S. Food and Drug Administration, advancing the quality assessment, regulatory evaluation, and scientific framework for biologics and biosimilars. • Led CMC regulatory evaluations for IND, BLA, and NDA submissions across multiple therapeutic areas, supporting the development and approval of innovative and high-quality medicines. • Conducted pre-license inspections of biologics manufacturing facilities worldwide to ensure cGMP compliance and manufacturing readiness for licensure. • Directed multidisciplinary research and cross-functional initiatives advancing the quality, potency assessment, and regulatory science of biologics and biosimilars, while contributing to FDA standards, guidance, and policy development.
Advanced research in tumor biology and therapeutic protein engineering while contributing to national dialogue on policies supporting scientific talent. • Featured in The Commercial Appeal for supporting U.S. Congressional advocacy for the H-1B visa bill promoting opportunities for highly skilled scientists.
Provided executive leadership for biologics research, development, and manufacturing operations supporting the commercialization of medical products.