Ambarish Singh
Senior Director Regulatory CMC Strategist (small molecules)
Constellation Pharmaceuticals
Dr. Ambarish Singh is a regulatory CMC strategist (small molecules) with experience in worldwide filing of regulatory documents to support clinical trials, marketing applications and life-cycle management of medicinal products. Ambarish has led/participated in many Health Authority interactions on CMC topics, such as, continuous manufacturing, application of process analytical technology (PAT), Quality by Design (QbD) based development and control strategies, regulatory starting materials, genotoxic impurities and other general topics.
Ambarish started his professional career by joining the Chemical Development Division of Bristol Myers Squibb (BMS), where he contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol, and Baraclude. In 2007, he transitioned into the Global Regulatory - CMC Division of BMS, where he and his team members worked on the world-wide filing of Eliquis, Daklinza and Sunvepra, in addition to supporting numerous programs in clinical development. In 2020, Ambarish joined Constellation Pharmaceuticals as the head of Regulatory-CMC department, where he is responsible for providing strategic guidance on the preparation and filing of regulatory CMC documents.
Ambarish holds a PhD in Organic Chemistry from the State University of New York at Stony Brook. He served as a post-doctoral fellow at the Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York. Ambarish has published several scientific articles, holds patents and has given numerous talks on drug development at Universities, Technical and Regulatory conferences.