Karen Keener
About Karen Keener
Karen Keener serves as the Director of Regulatory Affairs Advertising and Promotion at Aimmune Therapeutics, a position she has held since 2022. With a strong background in regulatory affairs across various companies, she has extensive experience in medical device vigilance and a solid understanding of both domestic and international regulations.
Work at Aimmune Therapeutics
Karen Keener has served as the Director of Regulatory Affairs Advertising and Promotion at Aimmune Therapeutics since 2022. In this role, she oversees regulatory strategies related to advertising and promotion, ensuring compliance with applicable regulations. Her position involves collaboration with various teams to support the company's mission in the therapeutic area.
Previous Experience at Baxter International Inc.
Prior to her current role, Karen Keener worked at Baxter International Inc. as Senior Manager of Regulatory Affairs for Global Labeling and Advertising and Promotion from 2017 to 2020. During her tenure, she was based in Round Lake, Illinois, and later in Deerfield, Illinois. Her responsibilities included managing regulatory compliance for advertising and promotional materials.
Experience at Dova Pharmaceuticals
Karen Keener held the position of Director of Regulatory Affairs Advertising Promotion and Labeling at Dova Pharmaceuticals from 2020 to 2022. In this role, she was responsible for overseeing regulatory compliance in advertising and labeling, contributing to the company's regulatory strategies during her time in Raleigh, North Carolina.
Educational Background
Karen Keener earned her Bachelor of Science degree in Biology and Psychology from the University of Wisconsin-La Crosse, where she studied from 1983 to 1986. She later pursued a Master of Science in Regulatory Affairs at Northeastern University from 2014 to 2017. Additionally, she studied Medical Technology at the Chicago Medical School at Rosalind Franklin University of Medicine and Science from 1989 to 1991.
Regulatory Affairs Expertise
Karen Keener possesses extensive experience in medical device vigilance and global reporting of adverse events. She has a strong working knowledge of both domestic and international regulations related to on-market support and the approval of new products. Her recognized ability to identify, interpret, and execute applicable regulations and standards enhances her effectiveness in regulatory affairs.