Team

Nick Lyon

Senior Director, CMC Regulatory Affairs

Nick Lyon joined CellCentric in September 2026.

He brings more than 30 years of regulatory affairs experience spanning the development phases, marketing applications, health authority interactions, and post-approval lifecycle management with specialism in hematological and oncology products.

Most recently, Nick led the CMC regulatory activities for RYTELO in myelodysplastic syndromes (MDS) at Geron Corporation from Phase 3 through to the NDA and MAA approvals. His key experience includes developing global regulatory CMC strategies, authoring QOS and Module 3 content, supporting FDA and EMA meetings, responding to health authority questions, and working closely with various technical teams and CDMOs.

Nick also brings extensive oncology experience from regulatory consulting roles at AbbVie and Janssen, and prior to that was Head of EU regulatory affairs for Actavis Biologics, as well as working in regulatory affairs at various other biopharmaceutical companies in the UK.

He holds an MSc in Biotechnology from the University of the West of England and a BSc in Pharmacology from the University of Leeds.