Alexandra Klein

Alexandra Klein  Senior Director | Principal Consultant, Regulatory Strategy

Alexandra (Alex) Klein is a global regulatory strategy executive and principal consultant with nearly 20 years of experience helping biopharmaceutical companies navigate complex product development and regulatory pathways to achieve clinical, regulatory, and commercial success. She advises emerging and established organizations across cell and gene therapy, oncology, rare disease, vaccines, immunology, and other innovative therapeutic areas.

Alex specializes in developing integrated regulatory strategies that align scientific, clinical, CMC, and business objectives to accelerate development timelines and maximize asset value. She serves as a trusted advisor to executive leadership teams on regulatory risk, portfolio prioritization, health authority engagement, expedited development opportunities, and global registration planning, helping organizations navigate critical milestones and accelerate the path to market. She brings extensive experience supporting global submissions, expedited programs, and regulatory interactions across the US and other major international health authorities.

Known for translating complex scientific and regulatory challenges into clear, actionable strategies, Alex partners closely with clients to advance innovative therapies, mitigate development risk, and create practical pathways toward regulatory approval and commercialization. Her collaborative approach and deep regulatory expertise enable organizations to make informed decisions at pivotal stages of product development.

Alexandra holds a BSc in Chemistry and an MSc in Biochemistry from the University of Wisconsin.