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Regulatory affairs certification (RAC) or relevant professional certification (e.g., ASQ Certified Quality Auditor) preferred but not required. Collaborate with cross-functional teams, including manufacturing, quality assurance, quality control, regulatory affairs, and supply chain, to address GMP-related issues and drive continuous improvement initiatives.
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Develop and maintain best practices, standards, and guidelines for data management, data governance, and data security in alignment with regulatory requirements and industry standards. Experience in developing partner led sales in collaboration with data platform and tool vendorsIn-depth knowledge of big data technologies such as Hadoop, Spark, Kafka, and cloud platforms such as AWS, Azure, GCP, Snowflake, Databricks, etc.
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Cross-functional Collaboration with various departments, including logistics, finance, Tax, legal, finance, Govt Affairs, ITQ/FSQ, Global Security, External Supply Chain, and Sourcing, to align global trade practices with overall business objectives.
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5 + years of submission/publishing Regulatory Affairs or Regulatory Operations experience in a biotech/pharmaceutical setting Understanding of all International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA guidance relevant to electronic regulatory submissions.
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This role will focus on project management and delivery, technical understanding of and experience with Nuclear Regulatory Commission (NRC) licensing, National Environmental Policy Act (NEPA) regulations and guidance, ESIA, interpersonal skills, and the ability to partner with clients, co-workers, and agency representatives.
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Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
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Must have a strong understanding of a firm back-office and financial reporting functions such as reserve formula, FOCUS report, possession and control, stock record, general ledger, trade blotters, margin requirements, time critical regulatory functions (e.g., buy-ins, sell outs), record retention, access control procedures, and cybersecurity.
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Demonstrates extensive knowledge of, and/or a proven record of success performing in a role that emphasizes analyzing client internal control practices and evaluating client compliance with import control regulatory requirements, and some knowledge of international trade and US Customs issues, such as:Associated documentary requirements;Knowledge of the analysis of client internal control practices; and,Knowledge of valuation of client compliance with import control regulatory requirements.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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Act as the primary Third-Party Risk Management (TPRM) lead in regulatory matters, including exams and meetings. Responsible for the global oversight and coordination of 2nd line of defense activities and programs related to third-party risk management, and serves as the primary advisor on third-party risk management to segment Chief Risk officers.
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Experience in at least one of the areas: leadership, planning, enrollment management, student affairs program development and evaluation, staffing, budget management, and supervision. This position will serve as a member of the aligned President's Cabinet and the Dean's Council and Student Affairs Leadership Team (SALT) at Anoka Technical College.
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Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR). Participation in FDA regulatory meetings, especially panel preparation and presentation Experience writing or updating clinical reports/documents.
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The AML Manager must be able to assess complex regulatory situations and assist business leaders in operationalizing applicable requirements. Overseeing the implementation of U.S. Bank's BSA/AML Program consistent with regulatory expectations and industry practice for assigned area(s) of coverage.
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What you will Bring: Juris Doctorate degree from an accredited Law SchoolActive license to practice law, with either admission to the bar of the State of Minnesota or a limited in-house counsel license to practice law in the State of Minnesota 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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JOB DESCRIPTION Job TitleSr. Manager- Regulatory AffairsJob DescriptionThe Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the lives of patients around the world.
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regulatory affairs jobs Title: regulatory affairs manager Company: Jobget in Brooklyn Center, MN
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