Ms. Cha is a strategic and tactical drug development leader for small emerging companies as well as established biopharma companies with global project teams. During her 26 years in Regulatory Affairs with emphasis on early development, she has filed >35 original INDs and >20 CTAs and has extensive experience with Agency meetings. Her product expertise is mainly in protein therapeutics for oncology including ~16 ADCs and immunoconjugates, ~12 antibodies, and ~10 new chemical entities.

Having gained her experience in various small companies, her regulatory affairs knowledge is broad including CMC/quality, nonclinical, and clinical areas as well as regulatory operations and safety reporting.

She holds a Master’s degree in Biomedical Science, MBA and Bachelor of Arts in Biology, all from Boston University