- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development plans, clinical protocols, and in the submission of certain regulatory documents. Support commercial in developing a strategy including ... plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing...patient selection strategy .- Construct and co- lead Advisory Panels at certain scientific conferences. … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary:The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) ... the predictive nature of potential CDx assays. Leads CDx project teams for the diagnostic , in full alignment with Global Project Teams (GPT) covering all areas from… more
- 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
- BeOne Medicines (Emeryville, CA)
- …will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for the ... stakeholders. **Essential** **Functions** **of** **the** **job:** + Develop European and/or UK regulatory strategy for the designated program, and contribute to… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides strategic advice ... regulations. You will act as the Global and/or Regional Regulatory Lead on complex or multiple products,...will manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned… more
- Bristol Myers Squibb (San Diego, CA)
- … Lead for a cutting edge RPT program + Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing ... Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to...177Lu,225-Ac, 161Tb, F18, Y90, etc. + Experience with clinical regulatory strategy in prostate cancer + Demonstrable… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. + Develop regulatory strategies for Change ... ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well...regulatory associates to register our devices worldwide. + Lead regulatory efforts required to follow new… more
- Abbott (Alameda, CA)
- …and ensures timely product registration and release for distribution. + As the Regulatory Affairs functional lead , oversee and optimize processes and team ... release planning. + Provide Regulatory input to product lifecycle planning and project strategy based upon regulatory changes + Monitor for and guide team in… more
- Abbott (Alameda, CA)
- …with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy , and provide executive management with ... contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/ strategy -and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/ strategy… more
- Abbott (Livermore, CA)
- …reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/ strategy -and-strength/tackling-student-debt-for-our-employees.html) student debt program and ... and get on with their lives. This position provides regulatory compliance leadership for the business, ensuring the policies,...with corporate policies + Acts as a Contract Administration lead and be able to train new hires +… more
- Danaher Corporation (New York, NY)
- …we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Director, Product ... Portfolio Strategy and Enablement role is responsible for supporting Beckman's...prioritizing Beckman's Immunoassay innovation and R&D pipeline for future diagnostic solutions, leading cross-functional initiatives, and capability building to… more
