Eli Zavialov
Senior Director, CMC Regulatory Affairs at GlaxoSmithKline | Global Strategy & Digital Transformation
- Role
- Senior Director, Head of Future Dossier Strategy and Digital Transformation, Cmc Regulatory Affairs at GSK
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Eli Zavialov
Regulatory CMC Affairs leader with 25+ years delivering global CMC strategy and execution across biologics, gene therapies, small molecules, and combination products, from candidate nomination through launch and lifecycle management. Proven track record driving accelerated approval pathways, mitigating CMC risk, and negotiating pragmatic outcomes with major Health Authorities.Former Chair of the ISPE PQLI ICH Q12 Implementation Team, with demonstrated impact shaping policy, influencing new regulatory guidelines, and enabling practical risk-based development approaches across industry.I build and scale high-performing teams, set clear operating cadence and accountability, and modernize CMC regulatory processes to improve submission quality, speed, and predictability.
Experience
Senior Director, Head of Future Dossier Strategy and Digital Transformation, Cmc Regulatory Affairs
Jan 2026 — Present
Education
University of Southern California
Ph.D., Organic Chemistry
1994 — 1998
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