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Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM

Principal Regulatory Consultant
Integrated Project Management Company, Inc.

Susan Carino, FRAPS, MBA, MS, PMP, RAC, SSM, DTM is a Principal Consultant with Integrated Project Management Company, Inc., (IPM). Susan is a founding member of IPM’s Center of Excellence (CoE) for Quality and Regulatory Affairs. She is also a member of IPM's Product Development Lifecycle Management CoE. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She leads diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests. She has managed projects in all stages of product development to ensure high quality and regulatory compliance ranging from discovery research, development, clinical trials, regulatory submissions, health authority information requests, product launches/commercialization, post-approval requirements/commitments, and global expansion. Susan specializes in streamlining regulatory submission processes, agile project management, and leveraging project management for successfully managing alliance partners.

Susan holds Regulatory Affairs Certification (RAC) and is the San Francisco Bay Area Chair for the Regulatory Affairs Professionals Society (RAPS). Susan is also a certified Project Management Professional (PMP) with the Project Management Institute (PMI). Susan is a certified Scaled Agile Professional SAFe®5 Scrum Master (SSM). She teaches regulatory, clinical, pharmaceutical, and medical device courses for the University of California at Berkeley Extension. Susan holds a Bachelor of Arts (BA) in Chemistry from Oberlin College, a Master of Science (MS) from the University of Wisconsin at Madison, and a Master of Business Administration (MBA) from Santa Clara University. Susan was awarded Distinguished Toastmaster (DTM) which represents the highest level of educational and leadership achievement from Toastmasters International. She was named a RAPS Fellow (FRAPS) in 2023.

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