Scott Cleve
About
Scott Cleve is from Boston, Massachusetts, United States. Scott is currently Vice President, Regulatory Operations, Information and Compliance at Daiichi Sankyo, Inc., located in Basking Ridge, New Jersey, United States. In Scott's previous role as a Vice President Regulatory Operations and Compliance at bluebird bio, Scott worked in until Jun 2022. Prior to joining bluebird bio, Scott was a Head of Global Regulatory Operations at Boehringer Ingelheim and held the position of Head of Global Regulatory Operations. Prior to that, Scott was a Director, Global Regulatory Operations at AbbVie from Nov 2013 to Aug 2016. Scott started working as Director, Regulatory Affairs at Astellas Pharma Global Development, Inc. in Apr 2011.
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Scott Cleve's current jobs
The Head of Global Regulatory Operations, Information and Compliance (GROIC) leads and directs activities related to the following Global Regulatory Affairs functions: Global Regulatory Operations, Global Regulatory Compliance, and Global Regulatory Information Management . This position plays a key role in the decision making and overall operations of Regulatory Affairs and has accountability for building a fit for purpose global operating model including procedures, systems and tools and strategy related to the function . This position will serve as the chair of the Global Regulatory Operations Committee, responsible for assessing risk, opportunities and plans related to regulatory operations, assessing resource capability/needs and mapping out a course towards the future of regulatory operations. This position also supports the larger Regulatory Affairs' success as a senior leader in GRA, with shared accountability for sub-function decisions and strategic decisions. This position leads multiple disciplines within the function and builds cross-functional and cross-regional relationships to maximize efficiency, sustainability, and the achievement of global and local business objectives. Additionally, this position authorizes decisions regarding improvement of local and global procedures and has a direct and indirect global impact that affects the successful delivery of global development objectives.