David H. Schubert

SVP, Regulatory & Quality at Carmot Therapeutics

David (Dave) Schubert joins Carmot Therapeutics as our new SVP of Regulatory and Quality. Dave comes to us with over 35 years of experience in regulatory, quality, drug development and process development. Most recently Dave was SVP Regulatory and Quality at Chiasma where he provided regulatory leadership and guidance to development, commercial, marketing, pharmacovigilance, corporate compliance and business development. Prior to Chiasma, Dave was VP Regulatory and Quality at Stealth Biotherapeutics Inc. a company developing novel and innovative mitochondrial targeted therapies for rare and common diseases. Dave has served as the regulatory and quality lead for several biotechs and his experience spans oral dosage forms, sterile injectables, cartridge/pen (combination products), and topicals (ophthalmic drops). In addition, Dave has wide-ranging GXP compliance experience supporting GLP, GCP, and GMP. Trained as a protein chemist, Dave started his career at the bench at Genetics Institute. It was here that he transitioned to large scale GMP process development, writing regulatory dossiers and supporting quality systems.

Timeline

  • SVP, Regulatory & Quality

    Current role

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