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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials.
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Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Join Takeda as a Director, Precision Medicine and Digital Health where you will be responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital health tools to enhance the value of our products across therapeutic areas.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ensure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Understand scientific principles and regulatory Device requirements relevant to global drug development and post-market support, including recent EU MDR and IVDR. Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide the team in establishing and building appropriate global regulatory strategies.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Serve as the Plan’s internal Compliance point of contact for Regulatory Affairs matters. Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits.
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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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As a Regulatory Affairs Infrastructure Licensing Advisor , your work will help bring to fruition the transmission and other major projects that will help power our planet, reduce carbon emissions and create cleaner air for everyone.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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We advise clients on, among other things, domestic and cross border M&A, IPOs, activism, capital markets and investor relations, public and regulatory affairs, geopolitical issues, litigation, crisis, cyber, employee engagement, digital, opinion research and on broader reputation campaigns.
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The position is an executive-level regulatory and government affairs position for Exelon. The primary purpose is to provide strategic guidance to the corporation regarding the advocacy and implementation of federal regulatory issues affecting the company; to develop and leverage relationships with key regulatory, executive and legislative bodies, particularly the Federal Energy Regulatory Commission (FERC); and to provide oversight and strategy for achieving company objectives regarding regulatory and public policy issues of interest to Exelon from a federal perspective.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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Minimum of 10-12 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma
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