Bruce Paolella
Principal Consultant Regulatory Affairs Opus Regulatory at Opus Regulatory Inc
Based in United States
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Seniority
Manager
Department
General Business & Management
Location
United States
Industry
Business Consulting and Services
Company size
131
Contact information
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b•••••••@opusregulatory.com
Phone
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Background
About Bruce Paolella
Over 20 years of Regulatory Affairs experience for pharmaceutical drugs across all phases of development including Regulatory Strategy, Labeling, Advertisement and Promotional Review, and Regulatory Operations. Led promotional review for 12 drug products in several therapeutic areas including Anti-Infectives, Analgesic, Addiction therapy and Women’s Health. Have participated in several successful negotiations with FDA (CDER) and other health authorities (Therapeutics Products Division, Canada). Extensive interactions with FDA OPDP on product launch materials, specialized campaigns and social medica guidance. Have excellent people management skills, managed a team of 23 colleagues within North America Regulatory, Promotional and Medical review teams.
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