John Alvino
Senior Director, Cmc-ra @Selecta Biosciences
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WORK HISTORY
Senior Director, Cmc-ra @Selecta Biosciences
SKILLS
ABOUT JOHN ALVINO
RAC certified with over 25 years of experience in Research, Biopharmaceuticals and CMC-Regulatory Affairs.Currently a CMC-RA product lead for an approved biologic leading a core team of 10-12 individuals in a matrix environment ensuring efficient RoW roll-out and variation management.Actively engaged with staff skill-development by advising with CMC-RA product development strategy, contributing toward project goal development and guiding staff through risk-based decisions.Actively engaged with staff self-development by coaching and mentoring, advising as necessary and providing performance feedback.Led two accelerated biologics through MA approvals both granted expedited registration pathways and each requiring unique agile CMC-RA strategies.Seasoned with leading health authority (HA) interactions ensuring briefing books are well prepared and by preparing the team for discussions through proper scenario planning.Skilled with Marketing Application submissions including EU MAA, JNDA, NDS, NBE filings, as well as, ROW filings in Latin America, Asia, Middle East and Africa.
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