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Michael C. Maloney, RAC |
Education
B.A., Biological Sciences, San Jose State University
Experience Highlights
Over 30 years experience in Regulatory Affairs.
Biographical Sketch
Michael C. Maloney, RAC, is the Executive Vice President of Development and Regulatory Services with Intertox, Inc., providing comprehensive regulatory affairs consulting services with regards to medical products, including medical devices, pharmaceuticals, and combination products. Mr. Maloney has over 30 years of regulatory affairs experience in the development and execution of successful regulatory strategies, and oversight of registrational programs leading to marketing authorizations of pharmaceutical and medical device products.
Mr. Maloney possesses a broad range of regulatory affairs experience including regulatory approval strategies; direct successful negotiations with FDA (CDRH, CDER, CBER); nonclinical safety and biological activity programs; clinical investigations to establish safety, proof-of-concept, and efficacy; dossier submissions in compliance with Common Technical Documents (CTD) requirements including electronic CTD (eCTD); negotiations with regulatory authorities concerning product labeling and advertizing and promotional materials; post-approval commitments; prior approval supplements for CMC; and international dossiers oversight (Health Canada, EMEA, CTAs, etc.).
Mr. Maloney has had direct responsibility for a variety of functional areas including regulatory affairs, nonclinical, clinical, and manufacturing and quality assurance, and has had regulatory oversight of a wide variety of successful FDA submissions (IND, BLA, SPA, PAS, CTA, IDE, PMA, 510(k), etc.). He has experience in both fully integrated and virtual medical products companies, and has held positions of increasing responsibilities including senior regulatory affairs positions and President of both LaHaye Laboratories and Emerald Pharmaceuticals. Before joining Intertox, Michael served as the Head of the Regulatory Affairs Department at ZymoGenetics, and was instrumental in both the BLA approval of RECOTHROM, and a $1.2 Billion co-development agreement with Bristol-Myers Squibb for Interferon lambda. Michael serves on the Board of Directors for Trace Detect, Inc., the Eastside Affiliate of the National Alliance on Mental Illness (also past President), and on the Board of Advisors for Viridac.
Mr. Maloney holds a BA degree in Biological Sciences from San Jose State University, and is Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society.
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Select Project Experience
Regulatory Affairs
• Headed Regulatory Affairs Department with oversight of 16 regulatory professionals, all product development candidates and commercial products (biological product and medical devices).
• Perfect record of 125+ annual on-time regulatory submissions with no refusals to file, worldwide.
• Developed successful regulatory strategies for various IND submissions leading to successful Phase 1, Phase 2 and Phase 3 clinical trials including SPAs.
• Regulatory oversight of worldwide clinical trials for Crohn's disease including IND protocol amendments and BLA planning.
• Secured $3.35 Million in venture capital funding, established the company, acquired the manufacturing facility of a pharmaceutical company and rapidly deployed Emerald’s CMO activities.
• Successfully negotiated Assets Purchase agreement and attendant Limited Partnership agreements for the former pharmaceutical manufacturing facility.