Shawna Rose
About Shawna Rose
Shawna Rose is a Senior Regulatory Affairs Director with extensive experience in the medical device and biotech industries. She has held various leadership roles in regulatory affairs and quality management, currently serving at Noveome Biotherapeutics, Inc.
Work at Noveome Biotherapeutics
Shawna Rose serves as the Sr. Regulatory Affairs Director at Noveome Biotherapeutics, Inc. since 2021. In this role, she is responsible for overseeing regulatory strategies and ensuring compliance with applicable regulations within the biotherapeutics sector. Her experience in regulatory affairs contributes to the company's mission of advancing innovative therapies.
Previous Experience in Regulatory Affairs
Prior to her current position, Shawna Rose held significant roles in regulatory affairs at various organizations. She worked as the Director of Regulatory Affairs at Devicor Medical Products from 2010 to 2019, and as Director of Regulatory Affairs and Head of Regulatory Affairs Operations at Medpace from 2019 to 2021. Additionally, she served as Sr. Manager of Regulatory Affairs at Biogen from 2007 to 2010 and as Senior Associate in Regulatory Affairs at Alkermes from 2001 to 2007.
Education and Expertise
Shawna Rose earned a Bachelor of Science degree in Science, Technology and Society from Montana Tech of the University of Montana, studying from 1985 to 1994. She completed her high school education at Butte High School, obtaining her diploma between 1983 and 1985. Her expertise includes Change Control and Quality Management Systems (QMS), as well as Good Manufacturing Practice (GMP) compliance.
Background in Quality and Regulatory Affairs
Shawna Rose has a strong background in quality and regulatory affairs, having served as Sr. Director of Quality and Regulatory Affairs at Leica Biosystems from 2016 to 2019. Her comprehensive understanding of regulatory requirements spans across the medical device, biotech, and pharmaceutical sectors, positioning her as a knowledgeable leader in the field.