Rajesh has 30 years of domestic and international experience with small and large companies covering aseptic and non-aseptic Quality Operations encompassing vaccines, biologics, drugs, APIs, clinical Quality Assurance and radiopharmaceuticals. Rajesh has played a lead role in successfully bringing pharmaceutical companies into compliance to ensure sustainable commercial product viability. In that regard, Rajesh has been the lead host for many companies to manage Regulatory Agency inspections providing direct oversight and address questions arising from inspections and CMC sections of product filings. Rajesh has also provided oversight for CMO and CROs with respect to external QA/QC and directly engaged in establishing Quality programs for clinical trials covering the selection of Principle Investigators, training, protocol reviews, approving exception reports, establishing blinded study protocols and direct Quality oversight of Regulatory inspections of domestic and foreign clinical sites. Rajesh has played a lead Quality role in the successful Regulatory approval and subsequent commercialization of key products such as, Rotavirus, Abraxane, Ramelteon and Rifaxamin. Rajesh holds a Ph.D. in biochemistry from Lancaster University, UK, and an MBA in business administration from Suffolk University, Boston, USA.