Harris Rotman

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.

Experience

1. Senior Vice President, Head of Global Regulatory Affairs

   Madrigal Pharmaceuticals

   Jul 2024 — Present · Conshohocken, PA, US

Education

• Cheltenham High School

  High School Diploma

  1982 — 1986

• Rutgers University

  B.S., Biological Sciences

  1986 — 1990

• Thomas Jefferson University

  Ph.D., Microbiology and Molecular Virology

  1990 — 1996

Skills

• Maintenance & Repair
• Pharmaceutics
• Cross-Functional Team Leadership
• Regulations
• Toxicology
• U.s. Food and Drug Administration (Fda)
• Pharmacovigilance
• Gmp
• Biologics
• Chemistry
• Standard Operating Procedure (Sop)
• Regulatory Affairs
• Medical Devices
• Clinical Research
• Clinical Development
• Regulatory Submissions
• Therapeutic Areas
• Leadership
• Drug Development
• CRO Management
• Cmc
• Pcr
• CRO
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• Neurology
• Medical Writing
• Ind