- Astellas Pharma (Northbrook, IL)
- …selection and stratification in clinical studies across all phases of drug development. As a Diagnostic Regulatory Strategy Lead , you will be the primary ... and late-stage drug programs. + Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA...mitigations + Lead and/or support preparation of diagnostic related regulatory submissions including IVDR clinical… more
- Amgen (Washington, DC)
- …a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization. As such, the Dx group ... support therapeutic product teams, including regulatory approval, commercialization, and diagnostic lifecycle plans + Lead efforts to oversee assay… more
- Regeneron Pharmaceuticals (Armonk, NY)
- … impacts and operational considerations _Diagnostics Project Execution:_ + Working with the Diagnostic Strategy Lead , define the diagnostic delivery ... etc.) within Regeneron's drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory...Dx/CDx activities, status, budget and timelines + Support Dx/CDx Strategy Lead and Dx/CDx management with information… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Central Regulatory Affairs at BD Explore innovative solutions in BD Central Regulatory Affairs (RA) - Regulatory Strategy Team. Develop expertise across ... processing, and maintenance of internal performance metric data + Support Regulatory Strategy team operations, including SharePoint site maintenance and… more
- GE HealthCare (Waukesha, WI)
- …the development and lifecycle management** of a diverse portfolio of diagnostic cardiology algorithms, ensuring regulatory compliance, clinical efficacy, and ... This Senior Director role reports to the CTO for Diagnostic Cardiology (DCAR) and is responsible for defining and...for GE HealthCare internal and external stakeholders. You will lead a team of high-performing technologists and clinical experts… more
- GE HealthCare (Waukesha, WI)
- … submissions, and marketing, based on intended clinical applications, business, and regulatory strategy + Establish and cultivate strategic academic partners ... and national meetings of professional societies + Manage medical materials for regulatory , marketing, and commercial activities + Lead medical reviews of… more
- GE HealthCare (Waukesha, WI)
- …driving the successful execution of New Product Introductions (NPIs) in the Diagnostic Cardiology business of GE HealthCare. This strategic leader defines and ... the timely delivery of innovative, high-quality products and solutions for the diagnostic electrocardiography (ECG) business. As the leader of the Program Management… more
- Bristol Myers Squibb (Princeton, NJ)
- …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... with business needs and enabling timely, compliant submissions + Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee,… more
- Danaher Corporation (Boston, MA)
- …will be fully remote. In this role, you will have the opportunity to: + Lead regulatory strategy and execution for external partnerships and product ... The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and/or Authorities)_ Responsibilities Include but are Not Limited to the Following: + Lead regulatory strategy and execution in collaboration with external ... Senior Regulatory Project Manager is responsible for regulatory strategy development and execution of Companion...of Companion Diagnostics (CDx) and IVD products. The Senior Regulatory Project Manager will provide oversight and lead… more