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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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Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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This position provides an opportunity to join the US Global Regulatory Policy & Advisory team as a subject matter expert, with a focus on providing policy guidance on the Fundamental Review of the Trading Book (‘FRTB’) / new Market Risk capital requirements within the US Agencies’ proposed adoption of the ‘Basel III Endgame.
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Leading new business architecture required to support the Regulatory Capital computation per the Federal Reserve Bank Basel III requirements across the IHC. Extensive experience with Federal Reserve Bank Basel III regulatory Capital requirements, preferably at a Large FBO.
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Any other tasks requested by Team Lead, Head of Regulatory Compliance, Chief Compliance Officer and Chief Legal and Compliance Officer. Working closely with the Head of Regulatory Compliance, Chief Compliance Officer, Chief Legal and Compliance Officer and Asia Compliance team, this individual will work to strengthen the Company’s overall RCMP, while ensuring the timely identification, resolution and documentation of update of regulatory and compliance issues.
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Experience in Business or System Administrator is a plusExperience with managing vendors/consultants/partners (e.g. external publishing vendor)Strong understanding of Regulatory Operation comprehensive roleDesirablePrior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferredExperience with BLAs/NDAs/MAAs preferredExpertise in Veeva RIM, system implementation experience a plus.
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The Regulatory Affairs Specialist is responsible for preparing Nutritional Facts and Ingredient Statements (reg sheets) for all products within the Bimbo Bakeries USA (BBU) organization, including private label brands and foodservice.
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Join our team to review company policies and documents related to creating enforceable mortgage loans, oversee our loan originator compensation program, and collaborate with our Chief Compliance Officer and Director of Mortgage Compliance Oversight to ensure regulatory compliance and stay updated on relevant laws and regulations impacting our operations.
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At Houston Methodist, the Biomedical Equipment Technician (BMET) II position is responsible for providing technical support for general medical equipment, physiological monitoring, surgical equipment, and conduct safety inspections for the organization and meet regulatory guidelines through the analysis, maintenance, calibration, installation, and upgrades on assigned medical and other electronic equipment.
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JOB SUMMARYUnder the direction of the Director of Licensing and Regulatory Services, provides legal support to in-house counsel, home health, hospice, home care, and senior living operations as part of a dynamic in-house legal department.
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Morgan, Lewis & Bockius LLP, one of the world's leading global law firms with offices in strategic hubs of commerce, law, and government across North America, Asia, Europe, and the Middle East, has an opening for an Administrative Services Coordinator, reporting to the Director of Administration.
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Understanding of regulatory requirements impacting the utility industry (SOX, HIPAA, NERC CIP, Smart Meter/Smart Grid, etc.) Stay current with industry trends, best practices, and regulatory requirements related to vendor risk management.
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We believe successful CMC regulatory strategy includes the use of science to provide a good understanding of products, a transferable manufacturing process, and a regulatory story that generates minimal questions during review.
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regulatory job Title: intern Company: Amgen
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