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The Director of Safety Regulatory Compliance is responsible for planning, managing, facilitating, and coordinating SMS activities throughout SEPTA. The Director of Safety Regulatory Compliance role encompasses developing and updating safety management policies.
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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.
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Style="box-sizing: border-box; font-family: inherit; font-size: inherit;"> Regulatory/Export Compliance Manager. Regulatory/Export Compliance Manager *Must be authorized to work in the United States without company sponsorship now or in the future.
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You will support Cash's vision by working together with other compliance and counsel, Data Science, and Operations teams to support the management of CCO related inquiries arising during audits, regulatory examinations, and other ad-hoc independent requests.
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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. Responsibilities The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies.
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Vanderbilt Health - Executive Search Team is conducting a national search for a Division Counsel - Compliance & Regulatory Attorney with a strong regulatory and compliance background, including expertise in federal and state fraud, waste and abuse laws and related regulations, Medicare and Medicaid (TennCare) regulations and conditions of participation, and clinical research compliance.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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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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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs.
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Contribute to the development, review and approval of written policies and procedures necessary for compliance with all Reliability Requirements applying to Calpine, specifically as they relate to: Generator Owner (GO) and Generator Operator (GOP) functions as defined by NERC.Assist in tracking regulatory enforcement actions litigated by the CFTC, CME, and FERC, and summarizing pertinent case facts.
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Conduct compliance regulatory risk assessments for lending products and services and craft and implement appropriate compliance risk treatments accordingly. Ability to understand and communicate legal and regulatory concepts and convert them into relevant, practical business requirements.
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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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Do you have 3+ years of experience in regulatory affairs, and do you have experience in labeling / preparing safety data sheets? Required Knowledge: Regulatory, Scientific / Technical, QA, Business acumen.
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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.
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Title: regulatory Company: Orange Code
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