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The Principal Analyst in the Regulatory Services Management team ("RSM") in FINRA's Department of Market Regulation and Transparency Services ("MRTS") is responsible for performing a wide variety of tasks in support of establishing and maintaining controls for RSM standard and non-standard reports to be delivered to the Regulatory Service Agreement (RSA) Exchanges and other FINRA customers, as applicable.
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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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O Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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As a member of the Risk & Regulatory Advisory team, you will advise financial institutions on a broad range of credit risk management topics including organization and governance; credit process optimization; risk rating model design, build and implementation; credit regulatory assessments; and Current Expected Credit Losses (CECL) process and tools.
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We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.
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The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is responsible for executing model risk management activities consistent with the framework, industry best-practice and regulatory guidance.
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Collaborate with cross-functional teams including members from assay development, software engineering, marketing, quality, regulatory, and others to execute complex product development projects.
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The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.
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The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project.
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The Senior Auditor will lead and/or participate on complex audits of Treasury, Accounting and Corporate Finance in areas including the Capital Adequacy Process, Liquidity Risk Management, Treasury Operations, Treasury Investment Portfolio, SEC Financial Statement Reporting, and Regulatory Reporting.
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Director, Model Validation for SHUSA Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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regulatory job Title: principal consultant Company: Parexel in Cambridge, MA
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