Ngoc-Tri Vo
Director Regulatory Affairs @Regeneron
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WORK HISTORY
Director Regulatory Affairs @Regeneron
Uxbridge, GB
Designated EU Asset Lead for LYNOZYFIC (linvoseltamab) Marketing authorisation• Regulatory oversight of linvoseltamab development program • EU/JP Regulatory representative for Strategic Program Team• Lead CMA renewal activities• Lead Japanese NDA activity for linvoseltamab including preparation of 2 PMDA briefing books (pre-NDA and end of phase 1 study)• Support linvoseltamab commercial launch in EU/UK/Switzerland/Japan• Line managing two direct reports• Lead Multiple Myeloma co-stimulatory assets (CD38 X CD28 and GPRC5D X CD28)• Mentor other regulatory colleagues• Provide training in regulatory activities• Work with biostatistics team to provide bio stat classes targeting regulatory affairs professional
EDUCATION
CPE Lyon
Master of Science (MS), Chemical Engineering
University of Cambridge
PhD, Organic chemistry
SKILLS
ABOUT NGOC-TRI VO
Director Regulatory Affairs at Regeneron Pharmaceuticals, Inc.
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