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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Advise the Vice Provost for International Affairs and other University leaders on emerging andor urgent threats and risks to University interests stemming from geopolitical or other safety and security developments in the United States and abroad.
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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.
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Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations. They will execute research contracts including own 3-5 HCE Master agreement execution from start to finish: For this they will collaborate closely with business strategy and operations BSO, Contracting, Procurement, Legal and HCC stakeholders.
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Key internal relationships include brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory. Other internal relationships include Public Affairs, Government Affairs & US Corp Giving & Social Impact.
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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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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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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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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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Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development.
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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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Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible for preparing CMC regulatory strategies that enable first pass approvals.
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Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer.
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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Princeton, NJ
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