Katy Rudnick
Vice President of US Regulatory Affairs and Head of Boyds US at Boyd Consultants at Boyds- Claim this Profile
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Bio
Rachel Schwipps
Katy is a highly skilled professional in Regulatory Affairs. She has many years of experience and continues to pursue educational opportunities to further grow her knowledge base in the pharmaceutical industry. She strives for high quality and compliant submissions and manages her teams to grow in their careers. She is well respected among her peers and is a valuable asset to any company.
Ryan Hernandez
I worked with Katy for years at Teva Pharmaceuticals and can honestly say she is an excellent regulatory professional. During that time, Katy achieved multiple approvals for original applications. She was able to handle a tremendous workload while maintaining a positive attitude. She was a pleasure to work with on critical projects. Katy developed strategies to resolve issues with the FDA to keep projects on track. Her projects never missed their submission or due dates. Katy has a proven track record of success. I highly recommend her for the lead of regulatory programs and projects.
Rachel Schwipps
Katy is a highly skilled professional in Regulatory Affairs. She has many years of experience and continues to pursue educational opportunities to further grow her knowledge base in the pharmaceutical industry. She strives for high quality and compliant submissions and manages her teams to grow in their careers. She is well respected among her peers and is a valuable asset to any company.
Ryan Hernandez
I worked with Katy for years at Teva Pharmaceuticals and can honestly say she is an excellent regulatory professional. During that time, Katy achieved multiple approvals for original applications. She was able to handle a tremendous workload while maintaining a positive attitude. She was a pleasure to work with on critical projects. Katy developed strategies to resolve issues with the FDA to keep projects on track. Her projects never missed their submission or due dates. Katy has a proven track record of success. I highly recommend her for the lead of regulatory programs and projects.
Rachel Schwipps
Katy is a highly skilled professional in Regulatory Affairs. She has many years of experience and continues to pursue educational opportunities to further grow her knowledge base in the pharmaceutical industry. She strives for high quality and compliant submissions and manages her teams to grow in their careers. She is well respected among her peers and is a valuable asset to any company.
Ryan Hernandez
I worked with Katy for years at Teva Pharmaceuticals and can honestly say she is an excellent regulatory professional. During that time, Katy achieved multiple approvals for original applications. She was able to handle a tremendous workload while maintaining a positive attitude. She was a pleasure to work with on critical projects. Katy developed strategies to resolve issues with the FDA to keep projects on track. Her projects never missed their submission or due dates. Katy has a proven track record of success. I highly recommend her for the lead of regulatory programs and projects.
Rachel Schwipps
Katy is a highly skilled professional in Regulatory Affairs. She has many years of experience and continues to pursue educational opportunities to further grow her knowledge base in the pharmaceutical industry. She strives for high quality and compliant submissions and manages her teams to grow in their careers. She is well respected among her peers and is a valuable asset to any company.
Ryan Hernandez
I worked with Katy for years at Teva Pharmaceuticals and can honestly say she is an excellent regulatory professional. During that time, Katy achieved multiple approvals for original applications. She was able to handle a tremendous workload while maintaining a positive attitude. She was a pleasure to work with on critical projects. Katy developed strategies to resolve issues with the FDA to keep projects on track. Her projects never missed their submission or due dates. Katy has a proven track record of success. I highly recommend her for the lead of regulatory programs and projects.
Experience
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Boyds
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United Kingdom
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Business Consulting and Services
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1 - 100 Employee
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Vice President of US Regulatory Affairs and Head of Boyds US at Boyd Consultants
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Sep 2021 - Present
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Lupin Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Director of Regulatory Affairs
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Sep 2020 - Aug 2021
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Lannett Company, Inc.
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Manager, Regulatory Affairs
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Jun 2014 - Jul 2020
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Teva Pharmaceuticals
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Israel
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Associate II
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Aug 2008 - Jun 2014
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Mars
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United States
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Manufacturing
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700 & Above Employee
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QC Laboratory Supervisor
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2004 - 2008
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Education
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2020 - 2025
University of Southern California
Doctor of Science, Regulatory Affairs -
2009 - 2013
Temple University
Master's degree, Quality Assurance/Regulatory Affairs -
Delaware Valley College
Certificate, Environmental Science -
2001 - 2003
Millersville University of Pennsylvania
Bachelor's degree, Marine Biology -
1999 - 2001
Ohio University
Marine Biology
Community
