Jackie Schumacher

Entrepreneur-in-Residence

Jackie has more than 35 years of diverse experience in global regulatory affairs, development, commercialization, and portfolio management from initial clinical investigation through registration.

Jackie recently completed 5 years as SVP of Regulatory and Quality at Rallybio where she was accountable for establishing a Global Regulatory Affairs capability within the company. Also, at Rallybio, Jackie defined, developed, and implemented an over-arching Quality Strategy, capability, and culture. For both disciplines, she was also accountable for the operational systems, which supported biotech product, medical device, and in vitro diagnostic development.

Prior to joining Rallybio, Jackie served as Vice President of Regulatory and Quality at Lyndra Therapeutics, with responsibilities for regulatory and quality strategies. Previously, she spent more than two decades in pharmaceutical sciences within Pfizer. During her time at Pfizer, she developed and led successful global CMC registration strategies for new small molecules, product enhancements, and combination products, and held regulatory leadership positions within the former Established Products Sterile Injectables organization.

She served on the Board of Directors for BIOCT (bioct.org). Jackie has mentored individuals in startups and biotech’s, through her previous engagements with Women in the Enterprise of Science and Technology (WEST), Nucleate Bio (Yale), and Harvard Innovation Challenge (HIC).

Jackie received a B.A. in chemistry and in classical studies from Hamilton College.