Regulatory Project Management
Lisa McCarthy is a Senior Regulatory Consultant with Boston Biodevelopment who focuses on the operational and project management aspects of the regulatory process, partnering with strategic regulatory affairs colleagues and cross-fucntional program team members. Lisa has more than 25 years of regulatory operational experience across diverse therapeutic areas, and has served as the regulatory program manager for INDs, NDAs, BLAs, and MAAs including the blockbuster Entyvio®.
Lisa has held permanent roles in various positions in Regulatory Operations, Regulatory Submission and Regulatory Project Management in large companies with established processes and in smaller companies where she developed and established working processes for submissions. She is versatile and collaborative with excellent organizational and time management skills, demonstrated by her ability to guide team members towards successful and on-time achievement of organizational goals.
As a consultant, Lisa has supported more than a dozen companies in various phases of clinical development ranging from pre-IND through NDA/BLA/MAAs.