Head of Science & Regulatory Advanced Cell Models - US
Sartorius · Home Office United States Of America
RegulatoryFull-timeCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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