Sanjay Jain, PhD, MBA
Executive Director, CMC Regulatory Strategy
Sanjay Jain is an Executive Director in Global Regulatory Affairs Strategy with nearly 30 years of experience in product development and regulation. He has deep experience in CMC and leads CMC writing teams, working across small and large molecules, including advanced therapies, biosimilars and combination products. Sanjay advises on global development and regulatory strategies, regulatory pathways, agency interactions and lifecycle management, covering development from preclinical stages through clinical authorization, expedited programs and due diligence.
Before joining Fortrea (formerly Labcorp, Covance, and Envigo), he held senior roles in biotechnology and pharmaceutical companies and previously served as a university lecturer in pharmaceutical sciences. He completed postdoctoral training in Drug Delivery at UCL and holds a PhD in Pharmaceutical Sciences, an MPharm (Gold Medalist) and an MBA in Pharmaceutical Management.