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Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines. Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Director of Security, Governance Risk & Compliance (Permanent Remote, US) Experience or familiarity with emerging Governance Risk & Compliance management, enablement, and automation technologies.
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Humana's Associate Vice President (AVP), Technology and Cybersecurity Risk works closely with all areas of Enterprise Information Protection (EIP), Internal Audit, Enterprise Risk Management, business units, regulatory agencies, and industry groups to ensure the company's technology and cybersecurity risks are effectively managed and compliance objectives are achieved.
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Strong understanding of regulatory requirements, standards, and frameworks such as SOX, NIST CFS, CIS Controls, etc. Governance Risk & Compliance Experience. Proven track record of developing and implementing information security governance, risk management, and compliance programs with a focus on automation.
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Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.
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Do you have previous experience in animal care and/or control (e.g., animal services officer, veterinarian assistant, attendant at an approved kennel) or regulatory compliance and enforcement, law enforcement, military, or related field.
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Lead NCATS Cybersecurity compliance efforts to follow the Risk Management Framework (RMF). · Ensure on time delivery of task order deliverables for cybersecurity compliance. Axle is seeking a Cybersecurity Compliance Lead to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translational Sciences located in Rockville, MD.
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As a full-service environmental consulting practice, services include impact assessment and planning, regulatory compliance and permitting, wetland and floodplain analysis, waterbody and water quality assessment, air quality permitting and management, environmental remediation, site due diligence, environmental noise assessment, pollution prevention planning, and climate action solutions.
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The Cybersecurity Compliance Lead will support day-to-day and project-based security activities, POA&M remediations, vulnerabilities impact, and remediation process for the on-premises and cloud environments.
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Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology.
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Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.
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Demonstrated knowledge of and experience applying the principles and methods of computer security and compliance programs as required by the Federal Information Security Management Act (FISMA) and National Institute of Technology and Standards (NIST) security policy, standards, procedures and guidelines.
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Maintain current, up-to-date knowledge and understanding of pharmaceutical issues, clinical research policies, regulations, best practices, and compliance requirements necessary to support domestic and international special project site clinical research pharmacy activities.
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Regulatory Compliance: Stay up to date with aviation regulations and certification requirements, and ensure that all electrical systems meet relevant standards and guidelines. Electrical System Design: Evaluate and design electrical, avionics and related systems for Hughes' broadband internet connectivity product, ensuring those designs meet performance, safety, and regulatory requirements.
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As a not-for-profit entity, FINRA (Financial Industry Regulatory Authority) operates under the oversight of the SEC and sits at the nexus of broker-dealers, policymakers and investors. Reviews a full workload consisting of communications with the public including retail and institutional sales material submitted by firms pursuant to the filings review program, provides written comments on whether this material complies with applicable rules and provides revisions necessary to bring the sales material into compliance.
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regulatory compliance jobs Title: pharmacy technician Company: Rite Aid in Rockville, MD
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