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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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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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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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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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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Assist the Regulatory Affairs Manager with compliance-related inquiries and certifications as needed. The Regulatory Affairs (RA) Analyst is responsible for ensuring compliance of raw material documentation, finished product documentation, and finished product packaging with internal specifications and external regulatory requirements.
$90,000 - $105,000Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Capability in managing deliverables essential for regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Professional certifications such as Certified Anti-Money Laundering Specialist (CAMS) or Certified Regulatory Compliance Manager (CRCM) highly preferred. 5-8 years' experience in a regulatory compliance role within financial services or fintech, with a focus on BSA / AML regulations and risk management.
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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe 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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RES is accepting applications for Scientist I (ecology/regulatory) for our Glen Burnie, MD office. Experience working with federal and state resource and regulatory agency personnel and various permitting processes.
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SES is hiring an (Associate) Regulatory Counsel to support our Regulatory Affairs & Government team in the Legal Department. Finally you will support other regulatory, policy and advocacy initiatives as may be assigned including those associated with transactions, mergers and acquisitions, and key customers as well as sanctions, privacy, antitrust, export control, cybersecurity, and more.
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Full span of experience must include: Statistical and financial modeling including Allowance for Credit Loss (ACL); Data analysis using SAS and Python; Risk management, including identification and mitigation of risks, and adherence to regulatory requirements; Processing large datasets using Python and SAS; and Conducting sensitivity tests and model stress testing.
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Support regulatory inquiries from the CFPB, FDIC, other federal regulatory authorities and bank partners. Experience handling regulatory matters and have prior relationships with relevant regulators at the CFPB, FDIC, OCC, and other relevant state and federal agencies.
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Senior Regulatory Affairs SpecialistWHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers.
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regulatory job Title: regulatory affairs specialist Company: Parexel
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