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More details on our benefits can be found on our website at to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Create processes and documentation to ensure strong technical support for CRM application users, including field users, Regulatory, Legal, OEC, Medical Affairs, Operations, and others, including management of Field Help Desk knowledge base.
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Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA.
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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. Required Knowledge: Regulatory, Scientific/Technical, QA, Business acumen.
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This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
$225,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Certification in Control Self-Assessment, Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM) + Provides education and monitors employees on the requirements of company policies and standards related to risk and control ownership, the development and execution of new products and services, regulatory change management, issue resolution, and control testing.
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Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Purpose and Scope:The Medical Lead, Oncology, MUS (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA.
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Join our team as a Senior SOX Auditor and contribute to the company’s commitment to maintaining robust internal controls and compliance with regulatory requirements. This highly skilled and experienced individual will perform independently under general direction of the SOX Manager, and should possess a strong background in financial controls, risk assessment, and compliance.
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With direction from EVP Social Responsibility Strategy and Affairs, and SVP, Social Responsibility, develop content plan that pulls data and information from across the industry within the context of the Innovation Center priority pillars, following global reporting guidance.
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Partner across functions to ensure robust systems in place to meet regulatory and stakeholder expectations in the areas of environmental compliance, product compliance, supplier conduct, and sustainability/ESG; support response to internal and external stakeholder information requests in these areas.
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A comprehensive understanding of global import/export requirements, incoterms, customs, letters of credit, regulatory compliance, and associated documentation is crucial. Ideal candidate will have a Bachelor's degree in Agriculture, Business Administration, International Business, Supply Chain or related four-year degree.
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Lead engagement with applicable regulatory authorities and internal stakeholders when required; represent FBIN as subject matter leader with external stakeholders. Our portfolio of brands includes Moen, House of Rohl, Aqualisa, SpringWell, Therma-Tru, Larson, Fiberon, Master Lock, SentrySafe and Yale residential.
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Understand the Medical/Legal/Regulatory (Veeva) review process and prepare all assets and documentation for submission and review in accordance with the client's Promotional Material. Proficiency using the Microsoft Suite of products (Outlook, Word, Excel, PowerPoint, Teams, SharePoint) and other systems (Kantata/Mavenlink, SmartSheet, Workfront.
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regulatory affairs jobs Title: intern in Deerfield, IL
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