Head of Science & Regulatory Advanced Cell Models - US

Sartorius seeks a Head of Science & Regulatory Advanced Cell Models to lead scientific validation and regulatory strategy for advanced cell model solutions in the U.S. market. This remote role involves directing a team, managing FDA and regulatory engagement initiatives, and building external scientific collaborations to drive adoption of alternative testing methodologies.

Responsibilities

• Define scientific validation and regulatory qualification strategies through coordination of scientific, regulatory, and stakeholder activities
• Establish evidence frameworks by prioritizing validation requirements and proof thresholds to build customer confidence
• Drive FDA and regulatory acceptance activities including ISTAND Pilot Program and new approach methodology qualifications
• Build scientific collaborations with key opinion leaders, academic institutions, and regulatory-science initiatives
• Lead scientific study design and validation assay development to generate differentiated evidence for applications

Requirements

• Master's degree in Life Sciences, Biotechnology, Pharmacology, Toxicology, or Regulatory Science
• 15+ years in scientific affairs, regulatory science, validation, or application development in life sciences or pharmaceutical industries
• Experience defining scientific evidence and regulatory qualification strategies in regulated environments like GLP or GxP
• Strong knowledge of advanced cell models, NAMs, toxicology assays, and drug discovery applications
• Proven ability to build scientific credibility through KOL networks, publications, and regulatory-science collaborations
• Demonstrated capacity to influence product and commercial decisions using scientific evidence and regulatory insights
• Willingness to travel domestically and internationally, including monthly visits to Ashland, MA office