Michael Sauter Email & Phone Number
Senior Director, Global Regulatory Operations @ Alexion Pharmaceuticals, Inc.
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Michael Sauter Location
- Scituate, MA, US
Michael Sauter Work
- 2024 -2024 Sr RIM Administrator SME, Contract (Short term assignment) @
- 2023 -2024 Senior Contract Project Manager, Digital for Regulatory at Moderna (c) @
- 2019 -2023 Senior Director, Global Regulatory Operations, and Regulatory Project Management @
- 2019 -2019 Sr Director Regulatory Operations @
- 2019 -2019 Substitute High School Science Teacher @ Scituate Public School
- 2016 -2018 Senior Director, Regulatory and Global Labeling Operations @
- 2016 -2017 Sr Consultant, Regulatory Operations and Technology, part-time @ 27Q, LLC
- now Senior Director, Global Regulatory Operations @
Michael Sauter Education
-
Masters (Leadership)
2015-2015 - University of Michigan
(Leadership, Organizational Leadership)
2000-2000 -
(Education)
1986-1989
Michael Sauter Skills
- Agile Methodologies
- Cybersecurity
- Regulatory Submissions
- Pharmaceutical Industry
- 21 CFR Part 11
- Regulatory Affairs
- Life Sciences
- Biopharmaceuticals
- Clinical Trials
- Clinical Development
- SOP
- Drug Development
- Validation
- Quality Management
- Healthcare Information Technology
- Business Strategy
- Big Data
- Analytics
- Information Technology
- Start-ups
- U.S. Food and Drug Administration (FDA)
- Strategic Planning
- Project Management
- Agile Project Management
- Cross-functional Team Leadership
- Relationship Builder
- Management
- Leadership
- eCTD
- Computer System Validation
- Wearables
- Digital Health Technology Insight
- Healthcare Innovation Champion
- Technology Evangelist
- Global Regulatory Operations
- Real World Data Insights
- Pharma/Biotech Expertise
- Organizational Evolution
- Healthcare Regulatory Mastery
- Chemistry & Science
- R&D technology solutions
- Innovation
- eTMF
- Executive Leadership
- Endorse
- Interpersonal Skills
- Communication
- Biotechnology
- FDA
- IND
- Regulatory Requirements
- Clinical Data Management
- Project & Information Management functions
- Data Analytics
- Big-Picture Business Intelligence
- Corporate/Brand Value Optimization
- Value Optimization
- Big Picture Business Intelligence
- u.s. Food and Drug Administration Fda
- Marketing Strategy
- Customer Service
- Process Improvement Engineer
- Chemistry and Science
- Marketing
- Outcome Based Model Proponent
- Project and Information Management Functions
- Microsoft Office
- Sales
- Start Ups
- Cross Functional Team Leadership
- Data Sciences
- Solutions Architect
- Data Science
- u.s. Food and Drug Administration
Michael Sauter Summary
- Michael Sauter, based in Scituate, MA, US, is currently a Senior Director, Global Regulatory Operations at Alexion Pharmaceuticals, Inc.. Michael Sauter brings experience from previous roles at axogen, fms LLC, Alexion Pharmaceuticals, Inc. and Sarepta Therapeutics. Michael Sauter holds a 2015 - 2015 Masters in Leadership. With a robust skill set that includes Agile Methodologies, Cybersecurity, Regulatory Submissions, Pharmaceutical Industry, 21 CFR Part 11 and more. Michael Sauter has 5 emails and 3 mobile phone numbers on RocketReach.
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Top Alexion Pharmaceuticals, Inc. Employees
Brian Meltzer
Vice President Clinical Research
New Haven, CT, US
Naeem Khan
Vice President, Medical Affairs, US
Boston, MA, US
Erica Deacon
VP, Head of IT and Digital, Alexion
Boston, MA, US
Mariana Nacht
VP, Head of Genomics Medicine, R and D
Boston, MA, US
Edward Feeley
Vice President, Head of US Value and Pricing
Boston, MA, US
Amit Gulwadi
Vice President- Head of Transformation
East Amwell Township, NJ, US
Jon Adair
Vice President, U.S. Strategic Accounts and Diagnostic
Fort Wayne, IN, US
Toby Freyman
Vice President of Business Development
Boston, MA, US
Sean Christie
Chief Financial Officer
Newton, MA, US
Dan Zuniga
Vice President, US Business Unit Lead Neurology
Winchester, MA, US
Sarah Rhee
Vice President, Head of Regulatory Affairs
Boston, MA, US
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