Results driven leader of global high performing regulatory and drug development teams with demonstration of results (many successful marketing application [NDAs, BLAs, MAAs] approvals and [INDs, CTXs] in different therapeutic areas including oncology, cardio-renal, pulmonary, and gout). Key driver defining, refining, and ensuring implementation of US/EU/Global regulatory strategy and significant involvement in corporate activities, including due diligence, as a member of senior management team including key cross-functional committees. Strategic leader: BLA/MAA, negotiated post-marketing commitments, positive Advisory Committee.