Cesar M.

Executive Director, Head of Regulatory Cmc @Neurocrine Biosciences

San Diego, CA, US
MOBILE NUMBERS
+18•••••••47

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WORK HISTORY

Jan 2023 — Present

Executive Director, Head of Regulatory Cmc @Neurocrine Biosciences

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San Diego, CA, US

EDUCATION

2014 — 2016

American Medical Writers Association

Essential Skills Certificate

2009 — 2011

San Diego State University

MS, Regulatory Affairs

2004 — 2007

Pepperdine Graziadio Business School

MBA

2012 — 2015

University of Southern California

Doctorate, Regulatory Science

1995 — 1997

California State University - East Bay

BS, Biology, Environmental Studies

SKILLS

Regulatory SubmissionsPharmaceuticsSmall MoleculesGmpClinical DevelopmentRegulatory AffairsSpanish-SpeakingCmcBiotechnologyDrug DevelopmentBiopharmaceuticalsCtaPharmaceutical IndustrySopFdaGlpNdaProtocolFormulationInd

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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