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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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Sr. Regulatory Affairs Specialist-CT/AMI. 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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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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15+ 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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You will coordinate a global overview of regulatory compliance and product stewardship practices, closely collaborating with stakeholders to embed Product Safety & Regulatory Affairs (PSRA) activities within our product development processes.
$45,000 - $55,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must be a law school graduate with an LLB or JD degree Must be admitted to the Pennsylvania Bar.5 or more years of experience working with laws and regulations related to litigation, commercial, energy, and/or regulatory law.
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As the Manager of Regulatory Reporting you must ensure all activities conducted are in compliance with governing regulations, internal policies and procedures for Houston Branch and Scotia Holding (USA), LLC. It includes preparation and review of regulatory reports, manages / coordinates the issues identified around AXIOM logic and data integrity / quality issues for Houston Branch's reporting perspective.
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Administers, coordinates and performs compliance responsibilities for Title VI, the Americans with Disabilities Act (ADA), Prevailing Wage programs under the Davis-Bacon Act on behalf of Fort Bend County, and the Fort Bend County Internal Compliance Program.
$72,238.4 - $90,313.6 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Franciscan Medical Group, as part of Virginia Mason Franciscan Health, is currently looking for a full-time Safety/Regulatory Program Coordinator for the Franciscan Clinical Support Services team in Tacoma, WA. We are seeking an experience Registered Nurse for an excellent opportunity to lead and coordinate the Franciscan Medical Group program for patient/staff safety and regulatory compliance.
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Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Compensation & Benefits for the Sr. Regulatory Operations Specialist.
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Experience with Regulatory Operations, CAT/OATS, regulatory reporting, exposure to blue sheets, whiteboard, GDPR. Citadel (Broker/Dealer) - candidate will be very comfortable with data, solid excel or database knowledge (SQL), ability to make large sets of regulatory data digestible.
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Sr. Manager Federal Regulatory Affairs. The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellation’s advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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In this role you will join a team of program managers, uphold and maintain the Cash App product's licensing and regulatory obligations, and manage projects and strategic initiatives concerning parties external to Cash App, such as regulators, partners, and consultants.
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regulatory job Title: sr regulatory affairs Company: Thermo Fisher Scientific
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