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Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI² TAU within our Global Regulatory Affairs organization, based remotely.
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An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
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Lead strategic planning and analysis for complex functions or programs with significant business, regulatory and/or technical challenges requiring subject matter expertise, particularly in faculty relations (complex investigations of faculty misconduct), grievance policy, harassment policy, conflict of interest and commitment policy and code of conduct policy.
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This will include working with a matrix team within PDCS (e.g. Clinical Supply Planning, Clinical Supply Management, CMC, Clinical Supply Leads) as well as with other key stakeholders (e.g. AO Strategic Planning, Quality, Regulatory Affairs, Finance.
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The Associate Director, Regulatory Affairs, Strategic Global Labeling Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation.
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As the Associate Director, Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects.
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The Associate Director, Global Clinical Demand Planning is responsible for the support and evolution of a robust clinical demand planning function and capability for Alexion’s rapidly growing and dynamic clinical pipeline.
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Associate Director of Regulatory Affairs. with expertise in hematology and oncology to join our Early Clinical Development team in New York. This hire will report to the Director of Regulatory Affairs and will play an essential role in the regulatory activities of global oncology trials in early clinical development.
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Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team (e.g., 510(k) premarket notifications, Premarket Approval (PMA) applications, Investigational Device Exemption (IDE) applications, Medical Devices Regulations (MDR), Notified Body requirements, CE Mark, In-country notifications, etc.
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Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head.
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The Associate Director, New Product Strategy will manage the strategic and tactical execution of new product strategy and planning from the time the file is submitted to the FDA to the point of product launch.
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Director, Legal and Regulatory Affairs. will support the Legal Department's mission by providing specialized legal services, with an emphasis on regulatory, intercompany, and reinsurance matters, to internal clients in a collaborative manner and to assist the General Counsel and Associate General Counsel in directing and coordinating the activities of the Legal Department.
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The Associate Director, Clinical Supply Chain will play a pivotal role in overseeing the strategic planning and execution of clinical supply chain operations. Collaborating closely with cross-functional teams including Clinical Operations, Manufacturing, Quality Assurance, and Regulatory Affairs to forecast demand, plan supply needs, and coordinate distribution activities.
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Reporting to the Director of Supply Chain, this position will involve managing end-to-end supply chain activities to ensure the timely delivery of clinical trial materials while adhering to budgetary and regulatory requirements.
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The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.
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strategic planning associate director regulatory affairs jobs Title: director in Suwanee, Georgia
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