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Scott Cleve Location
Boston, MA, US
Scott Cleve Work
2022 -now Vice President, Regulatory Operations, Information and Compliance @
2019 -2022 Vice President Regulatory Operations and Compliance @
2016 -2019 Head of Global Regulatory Operations @
2013 -2016 Director, Global Regulatory Operations @
2011 -2013 Director, Regulatory Affairs @ Astellas Pharma Global Development, Inc.
2005 -2011 Associate Director @ Astellas Pharma Global Development, Inc.
2000 -2005 Manager @ Technology Services Group, Inc.
1997 -2000 Consultant @
Scott Cleve Education
Loyola University Chicago 1993-1997
Thornwood High School
High School Diploma (College Preparatory Classes)
1989-1993
Northwestern University
MS (Quality Assurance and Regulatory Sciences)
2007
Scott Cleve Skills
Software Project Management
eCTD
Document Management
Regulatory Submissions
Organizational Leadership
Regulatory Affairs
Pharmaceuticals
SPL
Project Management
FDA
21 CFR Part 11
IND
NDA
Validation
Regulatory Operations
Computer System Validation
Electronic Submissions
Documentum
Process Improvement
Business Process Development
management
Organizational Development
Pharmaceutical Industry
Pharmacovigilance
GMP
Microsoft Excel
Organizational
Computer System
Electronic Common Technical Document Ectd
Business Process
u.s. Food and Drug Administration Fda
Software Project
Digitization
Electronic Common Technical Document
u.s. Food and Drug Administration
Scott Cleve Summary
Scott Cleve, based in Boston, MA, US, is currently a Vice President, Regulatory Operations, Information and Compliance at Daiichi Sankyo, Inc.. Scott Cleve brings experience from previous roles at bluebird bio, Boehringer Ingelheim, AbbVie and Astellas Pharma Global Development, Inc.. Scott Cleve holds a 1993 - 1997 Loyola University Chicago. With a robust skill set that includes Software Project Management, eCTD, Document Management, Regulatory Submissions, Organizational Leadership and more. Scott Cleve has 3 emails on RocketReach.
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