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Possible subject matter could include capstone design, regulatory affairs, medical device development, project management, quality engineering, rapid prototyping and design for manufacturability.
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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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Partner with a variety of Microsoft subject-matter experts (SMEs), including Commerce/Payments & FinTech, Privacy & Regulatory Affairs, Intellectual Property Group, Competition, Office of Critical Infrastructure, Office of Responsible AI, Digital Safety, Environmental Sustainability, and others, to track and interpret regulatory requirements and developments worldwide.
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As a key member of the AAHOA Advocacy/Government Affairs Team, the State & Local Government Affairs Director reports to the Senior Director of Government Affairs and works on a government affairs team of three professionals.
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Prior experience in real estate development, government and regulatory affairs, city and regional planning, or engineering is preferred. ▪ Prepares and delivers reports, writes white papers and organizes policy content on a variety of issues related to government affairs, planning and development, transportation, public utilities, and environmental planning.
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The role will report to a Vice President and Associate General Counsel, Global Risk and Regulatory Affairs, based in Washington DC. Visa is seeking a regulatory attorney to join its growing Global Risk & Regulatory Affairs group to proactively provide regulatory support to Visa’s Commercial & Money Movement Solutions (CMS) business.
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Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.
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1 or More Years in regulatory affairs required. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.
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A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. Title: Principal Regulatory Affairs Specialist.
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AIG’s Global Legal, Compliance, Regulatory and Government Affairs (GLCR) department is comprised of attorneys and other professionals providing high-quality advisory and transactional support with integrity and objectivity across all parts of the organization.
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Ensure alignment and collaboration with US, EU and IM countries, regional teams, medical affairs, patient engagement , market access, regulatory and commercial teams. Monitor regulatory changes, competitive landscape, and market trends specific to the indication to stay ahead.
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Frequently interact and collaborate with colleagues in the U.S. Immunology sales and marketing organization, regulatory affairs, medical affairs, and compliance. You will provide legal support to all elements of the cross-functional teams responsible for the launch and commercialization of U.S. Immunology brands and services.
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Additional non-study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late-stage compounds; Committee member, in-licensing and acquisitions.
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regulatory affairs jobs in Atlanta, NE, Arkansas
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