Roman Bradel, PhD
Associate Vice President, Regulatory Affairs
Roman’s 21-years of experience in regulatory affairs and regulatory compliance involves supporting early stage drug research and development to post-market support of large commercial products from small start-up to Fortune 500 companies across biologics, pharmaceutical, medical device, and food industries. He has an extensive background in the development and execution of complex regulatory strategies, domestically and internationally and has demonstrated success in regulatory submissions: INDs, CTAs, NDAs, BLAs, MAAs, Orphan Drug Designation, Fast Track, and briefing packages for regulatory meetings.
Besides being an expert in CMC Regulatory, Roman’s therapeutic experience includes immunology, immuno-oncology, oncology, gastroenterology, cardiovascular diseases and other therapeutic areas. And, his areas of expertise include authoring and management of regulatory submissions, gap assessment and remediation, and regulatory risk assessment and mitigation.
Roman holds a PhD in Chemistry from The Technical University of Berlin.