Cesar M.
Executive Director, Head of Regulatory Cmc @Neurocrine Biosciences
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WORK HISTORY
Executive Director, Head of Regulatory Cmc @Neurocrine Biosciences
San Diego, CA, US
EDUCATION
American Medical Writers Association
Essential Skills Certificate
San Diego State University
MS, Regulatory Affairs
Pepperdine Graziadio Business School
MBA
University of Southern California
Doctorate, Regulatory Science
California State University - East Bay
BS, Biology, Environmental Studies
SKILLS
ABOUT CESAR M.
I work tirelessly to get innovative life-changing therapeutics approved for use- patients are waiting!As a regulatory professional I work with company sponsors, partners, and global health authorities to build drug development CMC strategies that ensure the quality, safety, and efficacy of innovative therapeutics. Having worked in the pharma industry for over 20 years, I’m fortunate to have led CMC teams through successful global new drug product registrations, clinical trial applications, and lifecycle growth initiatives across various therapeutic areas, drug modalities (biologics, cell and gene therapy, peptides, enzymes, synthetics), and drug delivery systems including combination products, biologics large-volume SC delivery, and devices.As a proven leader in establishing regulatory teams and executing global strategies, I stay focused on patients, follow the science, seek win-wins, and promote continuous organizational learning.
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