Roman Bradel

Roman Bradel has extensive work experience in the field of regulatory affairs. Roman has worked as an Independent Consultant, providing regulatory support to various companies in the pharmaceutical industry. In this role, they act as the primary contact with FDA and provides expert advice in CMC related topics.

Prior to their consulting work, Bradel served as the Senior Director of Regulatory Affairs at ORYN THERAPEUTICS, Inc. Roman was responsible for devising regulatory strategies for the early-stage clinical development of Orynotides, a novel class of therapeutics. Roman also acted as the company's primary contact with FDA and led agency meetings.

Bradel also has experience as the Head of the Regulatory Affairs department at Prolacta Bioscience. In this role, they led early-stage clinical activities for the development of a drug product portfolio. Roman filed INDs in the US and provided regulatory support for commercial nutritional products.

Before Prolacta Bioscience, Bradel worked as the Executive Director of Regulatory Affairs at NewLink Genetics. Roman led the preparation activities for the company's first commercial cellular immunotherapy product and provided regulatory support for other product candidates in clinical trials.

Earlier in their career, Bradel was the Director of Regulatory Affairs at AbbVie, where they supported post-approval changes for HUMIRA®, the world's largest commercial biologic product. Roman also served as the regulatory lead on a new formulation for HUMIRA®.

Bradel began their career as an Associate Director of Global Regulatory Affairs at Emergent BioSolutions, where they supported post-approval changes for BIOTHRAX® and managed the submission preparation and review process.

Overall, Roman Bradel has demonstrated expertise in regulatory affairs, with a focus on pharmaceutical products and medical devices. Roman has extensive experience in devising regulatory strategies, leading agency meetings, preparing regulatory submissions, and providing expert advice to support the development and commercialization of various therapeutic products.

Roman Bradel's education history began in 1983 when they enrolled at Technische Universität Berlin. Roman completed their studies there in 1992 and obtained a Doctor of Philosophy (Ph.D.) degree in Medicinal and Pharmaceutical Chemistry.