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Head of Global Regulatory Affairs and Strategy @ Isomorphic Labs

Cambridge, Massachusetts, USOnsiteFull Time
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About this role

Head of Global Regulatory Affairs and Strategy at Isomorphic Labs. Location: Cambridge, Massachusetts, United States. Role: defining strategy, building team, ensuring compliance Requirements: 15+ years pharma/biotech regulatory experience leading programs from IND/CTA through NDA/BLA/MAA, proven ability to build and lead regulatory, quality and PV functions, knowledge of global registration and GxP, strong stakeholder influence and communication skills. Category: Legal and Compliance Seniority: Senior Level Tools: Electronic Common Technical Document (eCTD), Quality Management System (QMS) Commitment: Full Time Workplace: Hybrid Languages: English

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