Business savvy regulatory leader with a scientific background and 18+ years of experience in big pharma, small company and consulting environment with successively increasing levels of responsibility. Experience includes roles in CMC, regulatory operations, regulatory strategy, and people management. International exposure, good understanding of drug development and in-depth exposure to therapeutic areas like Oncology, Nephrology, Metabolism etc. Experience working with various health authorities. Experienced in working with small molecules as well as biologics.