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5 year prior experience in regulatory affairs within the dietary supplements or food industry, especially experience with an ingredient supplier is highly preferred. o Lead and execute regulatory affairs on customer documentation requests.
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Also, the DGA should have sound knowledge of data governance, quality, issue management, lineage & related tools, project management skills, controls, product management, assist in developing remediation plan(s) for data quality issues, specific regulatory and intrernal audit mandates related to data and data technologies.
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Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research. The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures.
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Responsibilities: The following regulatory duties will be performed under general supervision by the Assistant Director of Regulatory Affairs and/or Clinical Trials Manager-Regulatory Affairs: 1.
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Monitor and inform tax department of major U.S. tax developments and coordinate with internal government affairs team to develop lobbying strategy; The candidate must have a JD degree (LLM a plus) with 10+ years of experience at a law firm, Big 4 accounting firm or Fortune 500 company.
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Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network. Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network.
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Ensure regulatory compliance is met per NYS DHS, NYS OTDA, NYC FDNY, NYC Dept. of Health, NYC Coalition for the Homeless, etc., is adhered to. Ensure regulatory compliance is met per NYS DHS, NYS OTDA, NYC FDNY, NYC Dept. of Health, NYC Coalition for the Homeless, etc., is adhered to.
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As a RDS, you will partner with Risk Management Americas Division Market Risk experts to identify key data elements, historical data, data proxies and gaps, analyze the end-to-end process for market and regulatory reporting to clearly articulate inefficiencies, inaccuracies, data quality and control issues.
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Prepare and submit various permit applications to the Environmental Protection Agency, the US Army Corps of Engineers, the NYS Department of Environmental Conservation and other regulatory agencies.
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About the Opportunity: Shift: Day Shift Schedule: Monday to Friday Setting: Inpatient Responsibilities: The Respiratory Therapist Manager will be responsible for: Monitor state and federal regulations and those of other regulatory and accrediting agencies pertaining to departmental functions.
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Monthly program dashboards, data quality errors are fixed on monthly basis; reports and responses to funders submitted within required time frame;-Maintain oversight of all regulatory agency contracts (, OTDA, DHS, Coalition for the Continuum of Care, HUD, DOHMH, OMH, etc.
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Ranked in the 97th percentile by HRSA for clinical, financial, and regulatory performance. Close to the Bronx Park, the New York Botanical Gardens, and the Bronx Zoo.- Work and live in a thriving urban setting only 45 minutes from New York City.- PREFERRED: Ideal candidates will have 3+ years of experience.
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Conducts review of requests for prior authorization of health services, as required in certain product lines, and prepares written responses consistent with regulatory requirements. Reviews covered and coordinated services in accordance with established plan benefits, application of medical criteria and regulatory requirements to ensure appropriate appeal resolution and execution of the plan’s fiduciary responsibilities.
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Understand regulatory landscape and compliance requirements, with emphasis on applicable BSA/AML requirements for detection of potentially suspicious activity. The incumbent will be responsible for ensuing the L2 Investigations Team is effectively and efficiently conducting Level 2 investigations, escalations, and ultimate SAR Determination and filing meeting regulatory expectations for suspicious activity reporting and departmental SLA. They will be reporting to the FCC Director of the Alert, Investigations and Reporting Group.
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regulatory affairs jobs Title: sr Company: Usaa in Yonkers, NY
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