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Plumbing Inspector: Applicants must possess a valid license as a Plumbing Inspector of the appropriate level, High-Rise and Hazardous (HHS) or Industrial and Commercial (ICS), issued by the New Jersey Department of Community Affairs.
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Solid understanding of US regulatory rating framework and US regulatory requirements governing credit risk management, including origination, underwriting and portfolio management. Ensure accuracy of assigned credit risk and regulatory ratings and underlying rating model implementation.
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At minimum 10 years' experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
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Certification: Possess a certificate as a Certified Alcohol and Drug Counselor (CADC), issued by the Board of Marriage and Family Therapy Examiners, New Jersey Division of Consumer Affairs, Department of Law & Public Safety.
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The Regulatory Specialist will serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies.
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Clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
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Qualifications: Graduation from an accredited college with a Bachelor’s degree and one year of professional experience in housing and residence life or a related student affairs position is required.
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Provide training and support to Academic Affairs related to the use of critical technologies, with particular emphasis on Technolutions Slate CRMReporting Ensure that key campus constituents have access to critical graduate enrollment data and are able to maximize existing technologies to improve the prospective graduate student experience.
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Labor and Employment Counsel Advises all departments concerning labor matters, employment litigation, corporate, transactional and regulatory related legal matters. Ensures compliance with all Federal and State laws and regulations, CBAs, HMH policies, Joint Commission and other regulatory requirements as indicated.
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Collaborating with the Phillips 66 State Government Affairs Manager by tracking and engaging in state legislative activities and bills that may influence refinery business, recruiting refinery personnel participation as appropriate.
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Develop and implement food safety, food defense, and quality systems to ensure compliance with federal, state, and local government regulatory food safety requirements and Safe Quality Foods Institute (SQFI) or British Retail Consortium (BRC) standards.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Company Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Knowledge of regulatory guidance pertaining to enterprise risk and operational risk (e.g. FDIC, OCC, FRB, CFPB, etc.) Develops collaborative partnerships with internal departments, external auditors, regulatory agencies, and other stakeholders to support the company's Risk Management Framework.
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regulatory affairs jobs Title: sr director Company: Biogen in Rahway, NJ
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