Michael Vanderwerf Email & Phone Number
Vice President Regulatory Affairs @ Halozyme, Inc.
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Michael Vanderwerf Location
- Oceanside, CA, US
Michael Vanderwerf Work
- Vice President Regulatory Affairs @ (October 2022 - Present)
- Sr. Director, Regulatory Affairs @ (January 2017 - November 2022)
- Director - CMC Regulatory Affairs (Biologics) @ (September 2015 - Present)
- STAR Regulatory Consulting @ Regulatory and Compliance Consultant (March 2015 - Present)
- Chair, Biotechnology Advisory Board @ (January 2009 - Present)
- Director, Global Regulatory Affairs @ (January 2012 - January 2014)
- Director, Regulatory Affairs @ Shire Regenerative Medicine Division (January 2012 - January 2014)
- Assoc Director, Regulatory Affairs, CMC @ (January 2006 - January 2012)
- Senior Regulatory Affairs Scientist @ (January 2004 - January 2006)
- Director, Worldwide Compliance @ (January 2001 - January 2004)
- Director, Regulatory Affairs, Establishment Group @ (January 1998 - January 2001)
- Associate Director, Drug Regulatory Affairs @ (January 1995 - January 1998)
- Regulatory Affairs Manager @ Cambridge Biotech Corporation (January 1992 - January 1995)
- Operations Manager @ Endogen (January 1988 - January 1991)
- Technical Writer @ Cullinet Software (January 1987 - January 1988)
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
Bachelor's Degree (Biology and Philosophy of Science)
1986
Michael Vanderwerf Skills
- Biologics
- Biopharmaceuticals
- Biotechnology
- CAPA
- CMC
- CMC Regulatory Affairs
- Clinical Trials
- FDA
- FDA GMP
- GMP
- Global Regulatory Compliance
- Life Sciences
- Medical Devices
- Molecular & Cellular Biology
- Pharmaceutical Industry
- Quality Assurance
- Quality Improvement
- Quality System
- Quality System Compliance
- Quality Systems Design
- Regulatory Affairs
- Regulatory Analysis
- Regulatory Approvals
- Regulatory Compliance
- Regulatory Requirements
- Regulatory Submissions
- Root Cause Analysis
- SOP writing
- Technical writing
- Time Management
- U.S. Food and Drug Administration (FDA)
- eCTD
- 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 Biologics, Biopharmaceuticals, Biotechnology, CAPA, CMC and more. Michael Vanderwerf has 3 emails and 2 mobile phone numbers on RocketReach.
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