Lieselotte “Liz” Bloss, DVM, is a seasoned regulatory affairs leader with more than 30 years guiding drug developers through IND, NDA, BLA, and MAA submissions and the FDA and EMA interactions that surround them. She pairs deep global regulatory experience with a track record of moving complex programs to approval — including an oncology NDA approved in just 9.5 months.
As a Senior Partner and Head of Regulatory at The Bracken Group, Liz provides regulatory strategy and hands-on submission leadership across oncology, CNS, cardiovascular, women’s health, and rare disease. She prepares and leads sponsors through milestone FDA meetings — pre-IND, end-of-Phase-2, pre-NDA, and labeling negotiations — builds NDA Core and Rapid Response submission teams, runs regulatory gap analyses, and serves as US Agent for ex-US clients, often embedding directly as an interim Head of Regulatory.
Across roles at Taiho Oncology, Esperion, GE Healthcare, Kyowa Kirin, Bracco, and Novo Nordisk, she has authored and directed submissions to the FDA, EMA, and Health Canada, led labeling negotiations, and supported product launches. Clients engage Liz when a program needs an experienced regulatory strategist who can build the plan, lead the submission, and represent them credibly before the agencies.
End-to-end regulatory strategy from early development through approval and launch, across oncology, CNS, cardiovascular, and rare disease.
Planning, authoring, and leading high-quality IND, NDA, BLA, and MAA submissions, including NDA Core and Rapid Response Teams.
Preparing and leading sponsors through pre-IND, end-of-Phase-2, pre-NDA, and labeling meetings with FDA, EMA, and Health Canada.
Orphan Drug applications, Breakthrough readiness, and expedited-pathway strategy for rare-disease and oncology programs.
Label development and FDA labeling negotiations, plus Advisory Committee preparation and message alignment.
Embedding as Interim Head of Regulatory or regulatory lead, US Agent support for ex-US sponsors, and regulatory due diligence.
Bring Liz’s regulatory strategy and submission leadership to your next FDA or EMA program. Let’s discuss your project.
Work with Liz →
Consulting, creative/digital marketing, and data analytics for life science and digital health companies.
