Executive Vice President of Development and Regulatory Services
Few individuals have as broad a command of regulatory affairs as Mike Maloney. During his 30-year-career, Mike worked in all stages of pharmaceutical and medical device development and commercialization. It is this unique scope of regulatory expertise that Mike brings to Intertox.
Mike’s experience includes regulatory approval strategies; direct successful negotiations with FDA; nonclinical safety and biological activity programs; clinical investigations to establish safety, proof-of-concept, and efficacy; dossier submissions in compliance with Common Technical Documents requirements including electronic-CTD; negotiations with regulatory authorities concerning product labeling, advertising and promotional materials; post-approval commitments; prior approval supplements; and international dossiers oversight.
Before joining Intertox, Mike served as the Head of the Regulatory Affairs Department at ZymoGenetics, and was an important participant in both the BLA approval of RECOTHROM, and a $1.2 Billion co-development agreement with Bristol-Myers Squibb for Interferon lambda. Mike is Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society.
mcmaloney@intertox.com