Catherine Maher

REGULATORY AFFAIRS

Catherine Maher, PhD, RAC, is an experienced biopharmaceutical global regulatory affairs consultant spending many years leading corporate regulatory functions, ensuring strategy and responses to health authorities remain consistent, while developing partnerships across functions to advance product development and marketing approval. Her regulatory leadership has been instrumental in the FDA approval and commercialization of multiple first-in-class, drug-device combination products.

Prior to joining BRC, she led the approval of the novel contraceptive Phexxi® at a women's health company. Catherine also served as Head of Regulatory Affairs at Greenwich Biosciences, where she directed program-level regulatory strategy, all FDA interactions, and US applications for product development and approved products. While there, she also led the NDA strategy, submission, defense, FDA Advisory Committee meeting, and approval of Epidiolex®.

Catherine has built a strong foundation of regulatory expertise across multiple therapeutic areas throughout her career at Pfizer, Entremed (a biotech company specializing in oncology), and the Constella Group, where she served as a Senior Regulatory Affairs Consultant specializing in rare diseases.