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The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines. Receive and review revisions to USP, EP, JP, FDA regulatory guidelines.
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Oversee accurate calculations and Reporting of Average Manufacturer Price (AMP), Average Selling Price (ASP), Best Price (BP), and Non-Federal AMP (NFAMP) and 340B pricing to the appropriate regulatory entities for all Company and affiliate labeler codes.
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Contributes to safety management activities in cooperation with CHC Global Pharmacovigilance (GPV), Country PV teams, HA (Health Authorities), partner companies and other functions in compliance with global procedures and local regulatory PV requirements.
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Reporting to the CEO and liaising with the Board of Directors as the representative to the Board ERM Committee, the CRO oversees several key positions, including the Chief Credit Officer, Chief Information Security Officer, Director of Compliance/BSA/AML Officer, Fraud Officer, ILR Manager, and Compliance & Third-Party Risk Manager.
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The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and facilitate successful product development and market access.
$145,000 - $261,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Proven awareness of FDA governance concerning computer system validation, regulatory compliance, GMP, The UAT Lead is part of the Business Delivery Team (BDT) engaging in the global CTDO IT systems including SAP ERP in support of CTDO late stage clinical and commercial operations.
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Familiarity with financial regulatory compliance and anti-money laundering (AML) processes. Familiarity with financial regulatory compliance and anti-money laundering (AML) processes. Job Description: As an Oracle/Mantas Developer, your primary responsibility will be the development and maintenance of in-house products using Oracle/Mantas, specifically focusing on transaction monitoring tools.
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Advise business partners, CRM team members, and management on regulatory compliance requirements and best practices with respect to effective model risk management. Family Support – Care for loved ones with up to 16 weeks of paid leave for new parents, back-up dependent care, dependent care flexible spending account, and up to a $25,000 lifetime maximum during your adoption, infertility, or surrogacy journey.
$100,000 - $125,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience with regulatory compliance, GMP, and validation (CSV) Pharmaceutical, Bio-Technology, Life Science, or Cell Therapy industry experience. Strong working knowledge of MS Word, Excel (vlookup) or reporting, PowerPoint, Visio and Project Management.
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Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
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A solid understanding of all aspects of the pharma and / or biopharma industry in terms of Legal, Compliance, GxP, Computer Validation and Regulatory Requirements. In this role, you will be responsible for the overall management of the end-to-end finance functions in the US. This includes responsibility for compliance, talent management, performance, stability and cost efficiency of all IT processes and services provided for the Finance organizations from the IT function.
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Develop and maintain in-house products utilizing Oracle/Mantas, particularly transaction monitoring tools. Strong understanding of transaction monitoring concepts and methodologies. Experience with other Oracle products or technologies, such as Oracle Fusion Middleware or Oracle Business Intelligence.
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This is a full-time on-site role for a Safety and Compliance Manager at MIT Logistics Inc located in Kenvil, NJ. The Safety and Compliance Manager will be responsible for ensuring regulatory compliance, safety compliance, conducting training programs, and conducting accident investigations.
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Provide assistance to Regulatory Compliance Analysts in the development of Nutrition Facts Panels, Ingredient statements and allergen declaration statements for labels. The Document Control Coordinator will be responsible for performing document control activities for the Regulatory Department, including document request, tracking and uploading into network systems, including Genesis Nutritional software.
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As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. This group serves as the “center of excellence” supporting all US RA development projects and products across Ferring’s portfolio.
$174,000 - $254,150 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
regulatory compliance jobs in Morris Plains, NJ
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