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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for biologics submissions.
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$207,763 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Reporting to the Head of US and Above Market Compliance and Ethics Organization, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the US and Worldwide Commercialization Organizations.
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Develop and maintain data lineage documentation and mappings to support data governance, regulatory, compliance, and data lineage analysis activities. Strong understanding of data governance principles, data quality management concepts, and regulatory requirements.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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The Learning Experience Designer will apply instructional design principles, best practices, and creativity to develop a variety of learning resources to enable industry leading approach for training for Scientific Affairs and Medical Affairs.
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Publish, review, submission and archival of assigned global eCTDs and paper submissions using Regulatory Affairs systems/tool. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Knowledge of Bank Secrecy Act regulatory requirements, including CTRs and SARs, and basic knowledge of banking regulations. BSA Analyst responsibilities include: Administering the Bank Secrecy Act/Anti-Money Laundering Program and related procedures in accordance with Bank’s policies, procedures, and applicable federal regulations.
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Identify develop operational institutional pathways to grow scientific engagements research and data for the enterprise with a special focus on community oncology centers and accounts for ongoing working groups and consortium support Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Ewing, NJ
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