…12+ years of pharmaceutical industry experience 8+ years of experience working in regulatory affairs CMC Proficiency in regulatory (FDA, EMA, Health

…News and World Report every year since 1994. Primary Purpose The Director of Regulatory & Accreditation Affairs is responsible for leading the Parkland

…experience in creating and managing teams and integrating diverse inputs from Clinical/ Regulatory affairs , Scientific Affairs , Research & Development, and

…discipline 8+ years of pharmaceutical industry experience 6+ years of experience working in regulatory affairs CMC Experience in cell or gene therapy and device

…execution of clinical study protocols, timelines, and budget management Collaborate with Regulatory and Quality Affairs on clinical data analysis and post-market

…liaison between Clinical Development and other internal groups within Vertex (eg, Regulatory Affairs and Clinical Development Execution) for assigned studies, as

…between Clinical Development and other internal groups at Vertex (eg, Global Regulatory Affairs , Global Clinical Operations) for assigned studies * Represents

…liaison between Clinical Development and other internal groups at Vertex (eg, Regulatory Affairs , Clinical Development Execution) for assigned studies Represents

…liaison between Clinical Development and other internal groups at Vertex (eg, Regulatory Affairs , Clinical Development Execution) for assigned studies *

… affairs input to pivotal study design in close collaboration with Regulatory Affairs , Clinical Operations, Biometrics, and Commercial to ensure strategic