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Senior Vice President, Head of Global Regulatory Affairs @Madrigal Pharmaceuticals
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WORK HISTORY
Senior Vice President, Head of Global Regulatory Affairs @Madrigal Pharmaceuticals
Conshohocken, PA, US
EDUCATION
Cheltenham High School
High School Diploma
Rutgers University
B.S., Biological Sciences
Thomas Jefferson University
Ph.D., Microbiology and Molecular Virology
SKILLS
ABOUT HARRIS ROTMAN
Regulatory affairs professional with over twenty years of pharmaceutical industry experience and an additional eight years of scientific research training. Broad proficiencies include liaising with multiple regulatory agencies, investigational development, post-approval activities, application maintenance, advertising/promotion review, and medical writing. Functioned as the regulatory head of various US strategy and advertising/promotion groups and as the global therapeutic lead for assigned projects, and most recently as head of entire regulatory departments. Has managed multiple worldwide developmental projects (preclinical to phase 3) in neuroscience, cardiovascular, renal, dermatologic, analgesic, addiction, and gastrointestinal therapeutic areas, including rare/orphan disease products. Significant experience in evaluating and approving promotional campaigns. Has successfully supported and led dozens of health authority meetings/teleconferences with FDA, the EMA/CHMP, and national authorities in Canada, France, Germany, The Netherlands, Sweden, and The United Kingdom.
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