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Experience managing the entire cell-based assay lifecycle from development, Tech transfer, to commercial and being involved in the BLA/MAA regulatory submissions. Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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Advance Auto Parts is looking for a motivated, nimble, collaborative and experienced attorney to join our Ethics and Compliance (E&C) team as a Senior Counsel focused on data privacy and general legal compliance matters such as anti-bribery/anti-corruption, trade compliance and state and local retail-related regulatory matters.
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The Ambulatory Care Nurse Lead will also adhere to practice standards governed by all applicable state federal and regulatory agencies. The Ambulatory Care Nurse Lead will perform duties within the scope of practice ensuring consistency with hospital and WakeMed Physician Practices policies and procedures standards of care standing orders and evidence-based guidelines.
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The team provides an extensive range of financial accounting and reporting services with a comprehensive industry-focused approach like quarterly and annual financial reporting, fund administrator oversight, statutory and regulatory reporting including policy, production, SOX compliance and support, legal entity reporting preparation and filing, annual budgeting etc.
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Provide technical leadership in the areas of CCR ash basin closure, landfill design, solid waste management, groundwater and related regulatory, planning, design and construction phase projects.
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Preferred Qualifications Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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ResponsibilitiesUnder the general direction of the Associate Vice Chancellor, Strategic Communications and Brand Marketing, the Senior Director, Media Relations and Public Affairs will:-Build and maintain positive, constructive relationships with key contacts across the Chancellor’s Office and the CSU to aid in fulfilling media inquiries.
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We are looking for an innovative, dynamic, entrepreneurial, strategic leader with a wide array of technical expertise including data science, epidemiology, drug development, AI and machine learning as well as an in depth understanding of the pharmaceutical industry, regulatory strategy and evidence generation.
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Regulatory Compliance: CIS Framework, Azure Foundations and Microsoft Cloud Security benchmark. Certifications: CISM, CISSP, CISA, CCNA, CCNP-Security, Network+, Security+, CySA+, or other IT certifications reinforcing the ability to perform the duties of this role (IAT, IAM, DOD, etc.
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Considerable knowledge of FERC, NERC, SERC regulatory compliance. Construction, Electric Distribution Services, Electric Distribution Substations, Electric Generation, Electric SCADA, Smart Meter and Fiber Optics.
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Responsibilities: Revenue Cycle Oversight Billing and Collections Management Compliance and Regulatory Adherence Team Leadership and Development Financial Reporting and Analysis Qualifications: Bachelor's degree in Healthcare Administration, Business Administration, Finance, or a related field.
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The Head of Corporate & Legal Affairs will report directly to the CEO, with whom Cornerstone has had over a decade-long relationship and is a well-respected, collaborative leader with a rich history of working for start-ups and well-established CROs.
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Knowledge in variety of Federal Regulatory Compliance issues a plus: HIPAA, GLBA, Sarbanes Oxley SOX, FISMA , SCAP etc. General knowledge of current IT security fields including Firewall, IPS/IDS, Vulnerability Management, Network Scanners, PCI, Policy Compliance/GRC-IT and Audit Tools , other enterprise security solutions.
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Working knowledge of OSHA, NFPA, ANSI, ACGIH, ASME and other health and safety related regulatory and consensus standards. The EHS Specialist supports the EHS goals and functions of the pharmaceutical manufacturing facility.
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Harden landing zones, adopt blueprints and mature controls to ensure compliance with industry standards and regulatory expectations. The position is also responsible for ensuring appropriate First Line of Defense (FLOD) and SLOD stakeholders and governance forums are kept informed of progress, escalating as appropriate, and also act as the key point of contact with the various Regulatory bodies for these initiatives.
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regulatory affairs jobs Company: Jobget in Garner, NC
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