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Reporting to the Associate Director - GRA Plasma Lead (ANZAP), you will be responsible for Chemistry, Manufacturing & Controls (CMC) regulatory activities related to, registration and license maintenance for CSL products.
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Able to provide services in a timely, accurate, and cost-efficient manner in compliance with established System and regulatory standards, policies and procedures. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans.
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The Flight Operations Regulatory Compliance Program Manager is a subject matter expert in the safety systems, regulations, processes, and protocols that ensure compliance with all applicable regulations and safety of flight at Horizon Air. This role is responsible for investigations of non-compliance and the creation of corrective actions, preventative plans and tracking to reduce further occurrences.
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Communications / Contacts Internal - Departmental staff, business unit leaders/representatives, accounting managers, treasury and finance personnel, regulatory affairs cost of service department staff; and BHE corporate consolidations External - Federal Energy Regulatory Commission (FERC), Corporate Noteholders, Kansas Dept of Health & Environment, Environmental Protection Agency, auditing firms, IRS, pipeline journals.
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Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial.
$29.95 - $46.42 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Staff members in the Regulatory Affairs Department, including the Certifications Manager, and Policy/Procedures Development Administrator, will report to the Sr. Enterprise Regulatory Compliance Manager.
$126,400 - $189,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Has overall responsibility for Flight Operations regulatory compliance, including the management, compliance, and implementation of National Airlines Operations Specifications Parts A, B, and C.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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Environmental Permitting: Assist clients in navigating the regulatory permitting process, including obtaining permits for activities such as air emissions, wastewater discharge, wetland impact, and hazardous waste management.
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Policy ImplementationImplement and enforce third-party risk management policies and procedures, ensuring alignment with industry standards and regulatory requirements. Regulatory ComplianceStay abreast of changes in regulations and industry standards related to third-party risk management, ensuring ongoing compliance.
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The Sr. CRC. assists the Principal Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. The incumbent functions independently under minimal supervision, following FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator or manager as necessary.
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The Human Research Education Manager works within the CRRO (under the Office of Human Research Affairs) as well within the BU Clinical and Translational Science Institute (CTSI) Regulatory and Workforce Development Programs and helps to ensure activities support the BU CTSI’s mission and goals.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Model Risk ERP / EPM Implementation Regulatory Compliance (CCAR, BASEL, FRTB, etc.) The FSI Business Unit has led and managed projects for top-tier, global clients ranging from strategy, target operating model design, regulatory governance and remediation to technology transformation, program & project management, and business analysis.
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regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific
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