CMC
薬事
Natalie joined DHC in October 2026. A regulatory affairs professional specializing in regulatory affairs CMC for cell and gene therapy (CGT) products, she has over 20 years’ experience in cell and gene therapy development with a strong technical background. She is able to provide practical and strategic guidance on the regulatory requirements within CMC for a broad range of CGT products with an active, hands-on approach to ensure that wider teams are aware of, and understand, applicable regulatory requirements and current guidance.
Her career began in R&D with her PhD and postdoctoral posts in the development of viral vectors for treatment of haemophilia. She then joined the CMC team at GSK in 2012, where she worked on the late-stage development of autologous ex vivo gene therapy products, including STRIMVELIS. In 2017 she moved into regulatory affairs with her experience from here spanning regulatory CMC activities for early-stage CGT programs through to registration, health authority engagement, and global dossier authoring and strategy.
Early in her career, Natalie worked within the Regulatory CMC teams at the UK Cell and Gene Therapy Catapult, and BioMarin, supporting early-stage CGT development programs. At the Catapult she advised a wide range of CGT developers on CMC regulatory strategy and planned and authored module 3 dossier content. At BioMarin she was the portfolio lead for a number of AAV9 gene therapy products in early development through first-in-human clinical studies globally.
A significant achievement in Natalie’s professional career was as Head of Regulatory Affairs CMC at Adaptimmune where she was the Regulatory CMC lead for the late-stage development and registration of TECELRA (afamitresgene autoleucel), the first FDA-approved T cell receptor (TCR) gene therapy product. Here she led the regulatory CMC strategy for the BLA from dossier authoring and submission through to approval and post-approval activities. Most recently, Natalie was a Regulatory CMC lead within the Cell Therapy team at BMS, where she led the development of arlocabtagene autoleucel (arlo-cel), a late-stage GPRC5D-directed CAR-T product. This included management of regulatory CMC activities for Phase 2 and Phase 3 studies open globally in 31 countries in Europe, the Middle East, US, Canada, Latin America, and Asia-Pacific regions, plus leading a team supporting the future marketing applications across different regions (BLA/MAA/JNDA).
Natalie’s current interests include understanding the CMC challenges experienced for CGT and other complex products and how these can be mitigated. She additionally has a commitment to driving regulatory innovation and contributing to the wider CGT landscape, and serves as active member of the USP Lentivirus Gene Therapy Products Expert Panel.
Bristol Myers Squibb
Director, Global Regulatory Sciences, CMC – Cell Therapy
Adaptimmune
Senior Director, Head of Regulatory Affairs CMC
Director, Regulatory Affairs CMC
