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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The new hire in this role will lead the EHS program implementation, management, and improvement within the MC division including deployment of EHS programs and standards, EHS regulatory compliance, training, incident investigation, auditing, and performance evaluation; responsible for implementation and leadership of these programs among all Entegris commercial divisions and operating facilities with activities in the MC division.
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Strong knowledge of federal, state, and local EHS regulations (, OSHA, EPA, DOT) and proven experience in regulatory compliance. Coordinate and facilitate employee training programs on safety procedures, hazard recognition, emergency response protocols, and regulatory compliance.
$100,000 - $130,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advise on, develop, and support regulatory compliance International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), Foreign Trade Regulations, Dept. of Defense (DoD), Office of Foreign Assets Controls (OFAC), EU Common Military List, and other import/export regulatory requirements and laws.
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Minimum of 2 years of experience with quality systems, GMP regulatory compliance, methods and procedures for calibration and metrology within a pharmaceutical environment. Utilizing knowledge and understanding of cGMP (Current Good Manufacturing Practices), ISO standards, and the company's Quality Management System, the Facilities Coordinator will interface with multiple departments at multiple locations (Production Group, Quality Control, Quality Assurance, Research Products, Operations and Logistics) to ensure compliance with the company's Quality Management System, cGMP, and ISO standards.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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What You’ll Do: Reporting to the Lead Clinical Research Associate, the CRA II/Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP.
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Collaborate with agent and direct sourced factories to update and maintain regulatory trade compliance and social compliance documentation. Create, communicate, and maintain compliance policies and documents relative to physical and chemical testing (both regulatory and ASTM), quality, and social compliance.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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The Senior Instrument Validation Specialist is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to complete validation activities in compliance with corporate, regulatory, and industry standards and regulations.
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Familiarity with SOX compliance, ITAR compliance, NIST, and other regulatory frameworksRelevant certifications, such as Microsoft Certified: Azure Solutions Architect. Good understanding of security, privacy, and compliance requirements in enterprise environments, including data protection, identity management, and regulatory frameworks.
$42.31 - $63.46 an hourTemporaryExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This includes all documentation, regulatory compliance, patient care, and customer service skills required to complete molecular imaging procedures. 5) Maintain compliance with continuing education requirements for certification(s) and state licensure.
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Must have experience in leading large transformational engagements, specializing in organizational change management, process reengineering, complex technology deployments, and regulatory compliance.
ExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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As part of the Regulatory Analysis team, you will provide the legal research behind the content in our tax calculation and compliance engines. Proactively and continually monitor legislative and regulatory developments in the field of tax and regulatory reporting, with special emphasis on how such changes may impact Sovos’ systems.
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Key Responsibilities: 40% Compliance: Assist DC Asset Protection Manager with conducting monthly audit cadence that provides insight into shrink risk, overall safety compliance, merchandise accuracy audit completion, and regulatory compliance.
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In collaboration with the Nurse Manager, assures compliance with regulatory requirements and assures the unit is in a continuous state of readiness for a regulatory survey, i.e. Joint Commission, DPH.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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A Sr. CTC will work closely with the clinical project team to collect all essential regulatory documents for a clinical study (at both study and site level) in a timely fashion and store appropriately while ensuring compliance with ICH/GCP guidelines, federal regulations, and corporate policies and procedures.
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regulatory compliance jobs in North Reading, MA
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