Heather Kurtz

Senior Regulatory Affairs Consultant at Fang Consulting

Heather Kurtz is a Senior Regulatory Affairs Consultant at Fang Consulting. Heather has over 10 years of experience in the regulatory affairs field. Prior to joining Fang Consulting, Heather Kurtz worked as a Regulatory Affairs Associate at Pace Analytical for 9 years, where they were responsible for preparing and submitting annual reports for DMFs covering delivery system components. Heather also wrote new component DMFs and major DMF amendments, and submitted LOAs and Withdrawals of Authorization. Additionally, Heather Kurtz assisted in the development of eCTD compliant document templates.

Before Pace Analytical, Heather Kurtz worked as a Chemist 1 at Paddock Laboratories for 5 years, where they performed finished product testing for a pharmaceutical quality control laboratory using internal test and compendial methodology. Heather Kurtz also reviewed and revised analytical test methods and standard operating procedures. In addition, they performed reviews of documentation for testing completed by analysts in finished products, stability, and raw materials. While at Paddock Laboratories, Heather Kurtz also worked with a cross-functional team to develop a system to improve the handling of controlled substances in the lab, reducing analyst test times and improving laboratory compliance. Lastly, they co-developed laboratory orientation training for new analysts, providing a consistent introduction to the quality control laboratory.

Heather Kurtz has a Master of Science (M.S.) in Regulatory Affairs and Services from St. Cloud State University and a Bachelor of Arts (B.A.) in Psychology from Augustana University (SD). Heather is currently a chemist with the University of Minnesota.

Their manager is Tracy Eberly, President & CEO. They work with Isaac Erickson - Senior Regulatory Affairs Consultant, Brian Ellis - Regulatory Affairs - Senior Medical Writer, and Amy Hoover - Executive Administrative Assistant. A direct report to Heather Kurtz is and Matthew Griesbach - Regulatory Associate.

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