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Work with Senior regulatory personnel / Manager to identify regulatory and product registration needs and requirements for new products. Responsibilities: The Snr Product Regulatory Specialist is responsible for obtaining registrations and certification approvals for new and existing products, necessary to sell them to worldwide markets.
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Analytics Insights, Business, Business Direction, Client Relationship Management, Finance, Global Market, Marketing Strategies, Portfolio Management, Regulatory Compliance, Sales, Structured Products.
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Knowledge of SEC/FINRA/CFTC/NFA and other US based regulatory rules. Assist with surveillance of various regulatory reporting obligations, including: CAT, TRACE, LOPR, Swap Dealer Trade Reporting.
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The Director, Regulatory Genomics will have demonstrated expertise in regulatory writing and strategy as well as health authority interactions both written and verbal with a focus on genomics and genotoxicity evaluation.
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Our work spans all formulation types, novel technologies, and multiple modalities for small and large moleculesThe Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical products.
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The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical products. If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps-understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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Highly reputable, established, Fintech looking to appoint a Legal Counsel/ Financial Services Regulatory Counsel in NYC to expand their In-House legal and regulatory compliance capability/ team.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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Experience analyzing compliance with regulatory programsrelated to water, wastewater and/or air quality. For more detailed information, refer to the Regulatory Compliance Specialist job description.
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Director, Regulatory Affairs CMC. 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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US Army Corps of Engineers (USACE) Office of the Chief of Engineers (OCE), responsible for the Army Nuclear Power Program, is ramping up to meet a wide range of operational, engineering, logistic regulatory certification and permitting requirements for future Operational Readiness Review (ORR) in accordance with Army Regulation 50-7 "Army Reactor Program" (ARP.
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regulatory job Title: sr director Company: Csl Behring
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