Cindy Bueno

About Cindy Bueno

Regulatory Affairs professional with 15+ years of direct experience in both the biotech and pharmaceutical industry along with prior experience in a scientifically-related field as an Analytical Chemist. My career path has allowed me to demonstrate my skills at providing CMC, QA, and Clinical/GCP strategy, guidance and support to project teams across different stages of clinical development for both pharmaceutical and biotechnology products. I have functioned as the Regulatory lead in a face-to-face FDA meeting deemed to have had a successful outcome by upper management. Recognizing that submission of an NDA/BLA requires not only positive data, but also accountability for deliverables across functional areas, I strive to achieve my program’s clinical development milestones and the goals for which I am personally responsible through diligent planning and execution. I accomplish this in a professional and cooperative manner, fostering teamwork within regulatory and across departments. This approach allows me to quickly gain and maintain the respect of individuals at all levels while successfully achieving company goals.

Experience

1. Director, Regulatory Strategy

   Bristol Myers Squibb

   Nov 2020 — Present