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Collaborate cross-functionally with research, translational, clinical, and regulatory teams to advance cell therapy programs from preclinical development through to clinical trials and commercialization.
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As artificial intelligence and machine learning (AI/ML) solutions continue to evolve, we are committed to assessing and improving our AI/ML practices continuously based on our own learning, industry best practices and regulatory guidance.
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Work closely with Legal, Quality Management and Regulatory Affairs (QMRA), Compliance and other cross-business and functional stakeholders on activities related to enterprise-wide regulatory and quality management systems, including coordination, training, developing, and implementing plans, and providing input to systems designs.
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Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
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What you will Bring: Juris Doctorate degree from an accredited Law SchoolActive license to practice law, with either admission to the bar of the State of Minnesota or a limited in-house counsel license to practice law in the State of Minnesota 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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Support Sr Stock Plan Administrator with maintenance of company’s equity data using Fidelity Stock Plan. Ensure global equity reporting and compliance with international tax and regulatory requirements, including year-end equity related tax filings.
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Ensure compliance with worldwide regulatory standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity. Oversee quality systems to include change control, vendor qualification, records management, equipment and process validation, training and competency program and documentation, internal and external audits, standard operating standards (SOPs), process improvement, change control, and data review support.
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JOB DESCRIPTION Job TitleSr. Manager- Regulatory AffairsJob DescriptionThe Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the lives of patients around the world.
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This leadership role requires a strong blend of technical and soft skills, including but not limited to regulatory reporting, liquidity, data management, technology, risk management, negotiation, critical thinking, team building, relationship building, creative problem solving, and more.
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The Operations Manager is responsible for supporting the Restaurant Leader in leading operational excellence of the restaurant and upholding Raising Canes standards and culture in all areas of restaurant operations.
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As a Sr. Product Manager on the People Analytics team, you will work in the product model and will partner to develop a comprehensive product strategy, related roadmap, and set key business objectives (OKRs) for your respective product.
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Minimum three to five years banking experience required in commercial lending, regulatory examinations, or internal bank loan review. Previous experience in commercial lending and/or loan review specific job training required.
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Maintain a clean work environment and dental equipment to meet Park Dental, OSHA and Center for Disease Control sterilization and infection control regulatory standards. Maintain a clean work environment and dental equipment to meet Park Dental, OSHA and Center for Disease Control sterilization and infection control regulatory standards.
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Regularly inspect facility for safety hazards and either resolve them or report them to the safety manager as appropriate.
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As a Junior Regulatory Counsel, you will be primarily tasked with providing substantive research and scrutiny of tax laws. Proactively and continually monitor legislative and regulatory developments in the field of tax and regulatory reporting, with special emphasis on how such changes may impact Sovos’ systems.
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regulatory affairs jobs Title: affairs manager Company: Jobget in Plymouth, MN
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