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The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in delivering in-house RWE projects and support the development of Vaccines and Antivirals strategy to keep up with the evolving RWE landscape.
$218,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Demonstrate education and/or extensive work experience in a field relevant to global policy development (for example public policy, international affairs, regulatory compliance, knowledge management.
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Collaborates with relevant functions (Clinical Operations, Clinical Science, Pharmacology, Biostatistics, Regulatory Affairs, etc.) to deliver compliant datasets for regulatory submission.
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Stay ahead of trends and regulatory developments in cryptocurrency and fintech, offering legal solutions that support innovation and growth. You'll report directly to the General Counsel of Privacy and Business Affairs, acting as a vital bridge between legal and various global teams.
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Seniro Regulatory Affairs Specialist. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, Japan PMDA, other global regulatory agencies, submissions, dossiers and technical files.
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Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process.
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Professional - Sr Spec, Regulatory Affairs. Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
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Engage with regulatory agencies during submission reviews and provide on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, and other global regulatory authorities.
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AI/GenAI solutions for regulatory content or regulatory intelligence. Understanding of regulatory data and regulatory filing requirements. Regulatory digital transformations / innovations.
$322,875 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Reporting to the General Counsel, the Sr Manager of Regulatory Affairs & Compliance will play a critical role in overseeing and advancing FreedomCare’s compliance program. This role will have a deep understanding of healthcare regulatory frameworks and risk management, the Sr Manager of Regulatory Affairs & Compliance will ensure FreedomCare’s policies, procedures, and operations comply with laws and regulations.
$155,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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You should have prior experience in the AML/BSA space in an industry (for example, a financial institution) and/or regulatory capacity and proven research, analysis and writing skills. General knowledge in the BSA/AML space with industry experience working for a Financial Institution or regulatory body preferred.
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Support for regulatory publishing including assembling, printing, quality checking, archiving of regulatory submissions and corresponding data. Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.
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Experience in leading regulatory affairs across multiple major geographic areas and handling both small molecules and biologics. Ph. D. with over 10 years of experience in pharmaceutical regulatory affairs, or B.S/M.S. with over 12 years of relevant experience in biotech or pharmaceutical industries.
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This person will work with stakeholder departments such as Quality, Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and execution.
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The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.
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regulatory affairs jobs Title: sr in Corona, NY
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