- GRAIL (Albany, NY)
- …FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual ... affairs , quality, or program management within the IVD, medical device, or pharmaceutical industries is required. + Regulatory...+ Background in diagnostics or biomarker development, particularly in oncology , is a plus. + Regulatory Affairs … more
- Pfizer (New York, NY)
- …delivery of high-quality outputs, foster best practices, and identify process improvements withing Oncology Medical Affairs , as well as drive the integrated ... contributing to efficient decision-making processes in the development of Oncology Medical Affairs deliverables across...The Program Lead will provide overall program management to Global Medical Affairs Teams (GMAT),… more
- Sumitomo Pharma (Albany, NY)
- …highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology ** . The candidate must be deeply experienced in ... and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the...at least 10 years of direct experience in Regulatory Affairs in Oncology + Demonstrated experience in… more
- Sumitomo Pharma (Albany, NY)
- …Regulatory Affairs ( Oncology ).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Danaher Corporation (New York, NY)
- …product teams to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory, quality, etc.) on the ... Affairs , Clinical Affairs , Sales & Marketing, Corporate Development, Medical Affairs , and Market Access. Monitor and help facilitate the execution… more
- ICON Clinical Research (Farmingdale, NY)
- Manager, Scientific Affairs - Farmingdale NY - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... us on our mission to shape the future of clinical development. **Manager, Scientific Affairs - Farmingdale NY Hybrid** The Manager, Scientific Affairs , acts as a… more
- Pfizer (New York, NY)
- …partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology , precision ... efficacy (ESOE) and proof of concept (POC) studies in Oncology . You will work in close collaboration with the.... You will work in close collaboration with the Global Development Lead (GDL)and members of the development team… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …alignment to Global Skin Strategy. + Working in close collaboration with Clinical, Medical Affairs and Field Medical to ensure alignment with Medical ... Skin Cancer(NMSC) Skin Marketing, is a member of the Oncology Business Unit with accountability for leading the team...This position will report directly into the Executive Director, Global Skin Marketing. The Sr. Director of US Skin… more
- Sumitomo Pharma (Albany, NY)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... needs in oncology , urology, women's health, rare diseases, cell & gene...maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act… more
