Michael Vanderwerf Email & Phone Number
Vice President Regulatory Affairs @ Halozyme, Inc.
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Michael Vanderwerf Location
- Oceanside, CA, US
Michael Vanderwerf Work
- 2022 -now Vice President Regulatory Affairs @
- 2017 -2022 Sr. Director, Regulatory Affairs @
- 2015 -now Director - CMC Regulatory Affairs (Biologics) @
- 2015 -now STAR Regulatory Consulting @ Regulatory and Compliance Consultant
- 2009 -now Chair, Biotechnology Advisory Board @
- 2012 -2014 Director, Global Regulatory Affairs @
- 2012 -2014 Director, Regulatory Affairs @
- 2006 -2012 Assoc Director, Regulatory Affairs, CMC @
- 2004 -2006 Senior Regulatory Affairs Scientist @
- 2001 -2004 Director, Worldwide Compliance @
- 1998 -2001 Director, Regulatory Affairs, Establishment Group @
- 1995 -1998 Associate Director, Drug Regulatory Affairs @
- 1992 -1995 Regulatory Affairs Manager @ Cambridge Biotech Corporation
- now Operations Manager @ Endogen
- now Technical Writer @ Cullinet Software
Michael Vanderwerf Education
- The Johns Hopkins University
Master's Degree (Biotechnology)
2008-2010 - Harvard Extension School
Graduate-level coursework (Immunology and Government)
1988-1991 - University of Minnesota-Twin Cities
Bachelor's Degree (Biology and Philosophy of Science)
Michael Vanderwerf Skills
- Regulatory Affairs
- FDA
- Regulatory Submissions
- Regulatory Requirements
- Pharmaceutical Industry
- CMC
- Medical Devices
- Clinical Trials
- Biotechnology
- Biologics
- Biopharmaceuticals
- GMP
- Life Sciences
- eCTD
- Regulatory Compliance
- FDA GMP
- Regulatory Analysis
- SOP writing
- Technical writing
- Quality Systems Design
- Quality Improvement
- Quality Assurance
- Global Regulatory Compliance
- CMC Regulatory Affairs
- Molecular & Cellular Biology
- Root Cause Analysis
- CAPA
- Quality System
- Quality System Compliance
- U.S. Food and Drug Administration (FDA)
- Lifesciences
- Social Media
- Drug Development
- Process Validation
- Sales
- GLP
- cGMP
- Molecular and Cellular Biology
- Cmc Problem Solving
- Technology Transfer
- IND
- u.s. Food and Drug Administration Fda
- Microsoft Office
- Customer Service
- Vaccines
- Sop
- Regulatory Strategy
- Validation
- Regulatory
- Pharmaceutics
- Infectious Diseases
- Cell
- Software
- u.s. Food and Drug Administration
Michael Vanderwerf Summary
- Michael Vanderwerf, based in Oceanside, CA, US, is currently a Vice President Regulatory Affairs at Halozyme, Inc.. Michael Vanderwerf brings experience from previous roles at Halozyme, Inc., Teva Pharmaceuticals, Regulatory and Compliance Consultant and Parenteral Drug Association. Michael Vanderwerf holds a 2008 - 2010 Master's Degree in Biotechnology @ The Johns Hopkins University. With a robust skill set that includes Regulatory Affairs, FDA, Regulatory Submissions, Regulatory Requirements, Pharmaceutical Industry and more. Michael Vanderwerf has 3 emails and 2 mobile phone numbers on RocketReach.
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