Chuck Miller
Senior Vice President, Interim Head of Global Regulatory Science at Day One Biopharmaceuticals
- Role
- Senior Vice President, Interim Head of Global Regulatory Science at Day One Biopharmaceuticals
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Chuck Miller
Experienced industry leader with deep background across all aspects of Regulatory Affairs.• Demonstrated success leading multiple functional areas in parallel (Regulatory Affairs, Medical Writing, Quality Assurance, Pharmacovigilance, Manufacturing)• Successful track record with multiple global approvals (ZEJULA®, JEMPERLI®, INCIVEK®/INCIVO®, ZERBAXA®, TYZEKA®/SEBIVO®).• Experience with early development phase including specialty biologics (IMOJEV®, dostarlimab) and lifecycle management of fully developed assets (DIFICID®, CUBICIN®).• Regulatory group leader responsible for mentoring and career development.• Experience proactively building excellent working relationships with global regulators and multiple corporate partners.• Strong scientific background with direct knowledge and expertise developing, commercializing, and maintaining the life cycle of novel drugs and biologics.• Extensive experience providing strategic regulatory insight to research, development, and commercial organizations.
Experience
Senior Vice President, Interim Head of Global Regulatory Science
Feb 2026 — Present
Education
Boston University
BA, Biochemistry and Molecular Biology
1991 — 1995
Skills
- CRO
- Commercialization
- Clinical Development
- Clinical Research
- Regulatory Requirements
- Ind
- Cmc
- Nda
- Strategy
- Drug Development
- Gcp
- Biopharmaceuticals
- Validation
- Life Sciences
- Biologics
- Biotechnology
- Infectious Diseases
- Clinical Trials
- Regulatory Submissions
- R&D
- Neurology
- Product Launch
- Gxp
- Pharmaceutical Industry
- Fda
- Gmp
- Regulatory Affairs
- Vaccines
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