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Participates in the coordination and completion of multidisciplinary efforts in regard to regulatory preparedness and completion of applications (e.g. Hospital Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH/DOH or CMS corrective action plans, and clinical charter teams.
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Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. Among Dorsey’s many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota’s first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
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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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Under the direction of the Dental Board of California (Board) Anesthesia Unit (AU) Staff Services Manager I (SSM I), the Associate Governmental Program Analyst (AGPA) is independently responsible for providing analytical and consultative services in the legislative and regulatory process as it relates to anesthesia and sedation.
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Manages responses to requests involving Securities and Exchange Commission (SEC) oversight inspections and examinations, which includes the identification and collection of responsive documents, conducting due diligence reviews on proposed responses, drafting response letters, obtaining necessary supervisory approvals, and coordinating with other Regulatory Operations (RegOps) groups and FINRA’s Office of Oversight Liaison and Counsel (OLC) to make timely and accurate productions.
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The Regulatory Affairs Specialist is responsible for assisting the St. Croix Hospice Legal Department by filing, maintaining, and tracking government licenses and supporting documentation, responding to routine inquiries related to licensing, and supporting strategic growth efforts to obtain licenses.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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Regulatory Specialist III $74,297.60 - 119,620.80. Regulatory Specialist II $66,123.20 -101,836.80. Regulatory Specialist I $58,843.2 - 90,625.60. Maintains all compliance and regulatory documents for all departments; updates and monitors compliance tools with compliance documents filed with WECC and NERC; provides customer service support by providing assistance as needed to Standard Owners and Subject Matter Experts.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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As a Barclays US Basel IV Regulatory Capital Reporting Assistant Vice President (AVP), you will be working in the Regulatory Capital Team and will be tasked with the development and on-going circulation and reporting of both point in time and Comprehensive Capital Analysis and Review (CCAR) Projected risk weighted assets (RWAs), capital leverage, and Single Counterparty Credit Limits (SCCL) Large Exposures for Barclays IHC (Intermediate Holding Company) to internal and external stakeholders.
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QUALIFICATIONS A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Interface with regulatory agencies such as the Energy Facility Site Evaluation Council, Washington State Department of Ecology, and Washington State Department of Health. Provide technical advice and proactive counsel to management on a wide range of complex environmental regulatory issues, interpretation and verification of industry guidance, and regulatory requirements for application to plant specific issues.
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The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies.
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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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Title: regulatory Company: Clarivate Plc
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