Amy Hardwick

Amy Hardwick: Email & Phone Number

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Director, Regulatory Affairs (CMC) at Halozyme, Inc.|San Diego, California, United States

Position:

Director, Regulatory Affairs (CMC) at Halozyme, Inc.

Location:

San Diego, California, United States

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Last updated: 2026-06-23
Updated: 2026-06-23

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Work Experience 23 years

Director, Regulatory Affairs (CMC) at Halozyme, Inc.

Jun 2025 - Current

Owner at GreeneWorks Publishing LLC

May 2024 - Current

Owner at Haven Organizing + Decor LLC

May 2021 - Current

Technical Regulatory Program Director, Cell & Gene Therapy at Genentech

Jul 2021 - May 2025

Technical Regulatory Program Associate Director, iNeST at Genentech

May 2020 - Jul 2021

Regulatory Affairs Manager at Illumina

Apr 2019 - Apr 2020

Sr. Regulatory Affairs Specialist at Thermo Fisher Scientific

Sep 2017 - Apr 2019

Technical Regulatory Program Associate Director, CMC at Genentech

Sep 2013 - Apr 2016

Regulatory Compliance Analyst, MDR at Roche

Jan 2010 - Jan 2013

Change Management Consultant at Roche

Jan 2007 - Jan 2010

QC Scientist at Roche

Jan 2006 - Jan 2007

Analytical Chemist at Eli Lilly and Company

Jan 2003 - Jan 2006

Amy Hardwick started working in 2003, then the employee has changed 7 companies and 10 jobs. On average, Amy Hardwick works for one company for 2 years 5 months.

Amy is proficient in Spanish. Their professional focus is 21 CFR 803, 21 CFR 820, and Annual Reports across 3 core areas.

Amy holds Regulatory Affairs Certification (RAC) and American Mensa Member certifications and has been awarded Charles Yang Collaboration Award, Exceptional Contributor Award, and Quality Advocate Award

Education

Master of Science - MS at University of Southern California

Certificate at Yale School of Management

Certificate at Cornell University

Bachelor of Science - BS at Ball State University

Certificate at IAP Career College

Amy Hardwick Namesakes

Name
Company
Position
Amy Hardwick
Cosby High School, Chesterfield County Public Schools
School Librarian
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Supervisor, Manufacturing Operations
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Jennifer Rueffert
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Michael
Senior Manager, Quality Assurance
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Sandy Miller
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Bob Toe
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Nabeel Abokor
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