Amy H Email & Phone Number
Director, Regulatory Affairs (CMC) @ Halozyme, Inc.
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Amy H Location
- San Diego, CA, US
Amy H Work
- 2025 -now Director, Regulatory Affairs (CMC) @
- 2024 -now Owner @
- 2021 -now Owner @
- 2021 -2025 Technical Regulatory Program Director, Cell and Gene Therapy @
- 2020 -2021 Technical Regulatory Program Associate Director, iNeST @
- 2019 -2020 Regulatory Affairs Manager @
- 2017 -2019 Sr. Regulatory Affairs Specialist @
- 2013 -2016 Technical Regulatory Program Associate Director, CMC @
- 2010 -2013 Regulatory Compliance Analyst, MDR @
- 2007 -2010 Change Management Consultant @
- 2006 -2007 QC Scientist @
- 2003 -2006 Analytical Chemist @ Eli Lilly and Company
Amy H Education
- IAP Career College
Certificate (Interior Decorator)
2023-2023 - IAP Career College
Certificate (Professional Organizer)
2023-2023 - University of Southern California
Master of Science - MS (Regulatory Science)
2011-2014 - Ball State University
Bachelor of Science - BS (Chemistry)
2000-2003 - Yale School of Management
Certificate (Women's Leadership Program)
2025 - Cornell University
Certificate (Regulatory Leadership Program)
2025
Amy H Skills
- Gene Therapy
- Cell Therapy
- CMC Regulatory Affairs
- Chemistry, Manufacturing, and Controls (CMC)
- Clinical Development
- Interior Decorating
- Color Selection
- Home Organization
- Office Organization
- Time Management
- Space Planning
- Regulatory Affairs
- FDA
- Change Management
- U.S. Food and Drug Administration (FDA)
- FDA GMP
- U.S. Title 21 CFR Part 11 Regulation
- Regulatory Submissions
- Regulatory Requirements
- Regulatory Compliance
- Regulations
- Annual Reports
- Change Control
- Biotechnology
- Medical Devices
- 21 CFR 820
- 21 CFR 803
- Quality Management System (QMS)
- Microsoft Excel
- Microsoft PowerPoint
Amy H Summary
- Amy H, based in San Diego, CA, US, is currently a Director, Regulatory Affairs (CMC) at Halozyme, Inc.. Amy H brings experience from previous roles at GreeneWorks Publishing LLC, Haven Organizing + Decor LLC and Genentech. Amy H holds a 2023 - 2023 Certificate in Interior Decorator @ IAP Career College. With a robust skill set that includes Gene Therapy, Cell Therapy, CMC Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC), Clinical Development and more. Amy H has 1 emails on RocketReach.
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