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Ulli Kay Becker, PhD

Ulli is a passionate problem-solver and lifetime learner. She brings experience in FDA related products from product inception and development through application and post-market. 

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More about Ulli

Ulli is a results-driven project manager and regulatory professional, most recently with 12+ years of experience completing projects on time in diverse areas such as technology development, product development, quality systems improvements, and developing and submitting substantial equivalence submissions for novel tobacco products to the FDA. She is adept at data-driven decision-making to uphold the highest scientific and ethical standards. Ulli has an extensive background in regulated industries—including analytical laboratories and tobacco manufacturing—with a strong foundation in quality management. In her roles as scientist and business leader, she developed experience presenting technical material to expert audiences and translating complex science for non-technical stakeholders.

Prior to joining Sanova, Ulli served as Chief Scientific Officer at HBI Innovations where she led the preparation and submission of SE dossiers for novel tobacco products, maintaining sole ownership and accountability for all FDA submissions. She managed end-to-end FDA regulatory projects filed with the FDA, including partnering with external vendors adn laboratories to define data requirements, overseeing study execution, and compiling scientifically sound submissions.

Ulli also worked for Becton Dickerson and Eurofins (Lancaster Labs at RJ Reynolds) where she managed quality control and quality assurance groups, revising quality procedures, analytical protocols, managing OOS and non-conformities, and supporting ISO 13485 certification. She also worked at Lorillard Tobacco Company as Senior Research Chemist supporting product development and innovation.

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