Pushpa Singh, PhD

CMC Regulatory

Dr. Singh is a Pharmaceutical R&D executive with over 30+ years of experience in all phases of product development including discovery, development, technology transfer, and product life-cycle management. As a Vice President, Quality Operations & CMC Regulatory at Keryx Biopharmaceuticals, she was responsible for the overall strategic and operational activities in ensuring quality and regulatory compliance in the production and analysis of clinical trial materials. She was also responsible for all aspects of CMC documentation and regulatory activities in support of investigational and registrational submissions.

As an Executive Director at Bristol-Myers Squibb, she led a diverse organization requiring detailed and thorough review of technical information for Quality and GMP Compliance, CMC Technical Documentation, and Environment, Health & Safety.  She provided strategic thinking and long range planning for groups involved in strategic planning and development portfolio analysis.

Dr. Singh has extensive experience in the preparation of CMC section of global investigational (IND/CTA), registrational (NDA/MAA/BLA) and LCM submissions for small molecules and biologics, regulatory agency interactions such as end-of-phase 2 and pre-NDA meetings with the FDA, and regulatory agency inspections.

Dr. Singh received her Ph.D. in Organic Chemistry from Massachusetts Institute of Technology, and subsequently did postdoctoral work at Oxford University.  She has published 17 papers and holds 5 patents.