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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Under general direction of the Manager of Legislative Affairs, the Senior Legislative Affairs Analyst provides project management and analytical support to implement the department’s local, state and federal legislative agenda to promote solutions to homelessness aligned to HSH’s Strategic Plan and ensure compliance with legislative requirements.
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Demonstrated interest in public policy and politics, with a prior role on Capitol Hill, at a think tank, a public affairs firm, or a similar organization focused on government affairs. to lead a team of analysts serving Government Affairs executives and policy experts with high-quality research, analysis and data visualization in a fast-paced environment.
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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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Recruiting Practice Director, Regulatory Affairs (Pharma) Experience placing Regulatory Affairs professionals in CMC, Ad Promo, Labeling, Regulatory Strategy, etc. Cultivating long-term partnerships with key stakeholders in Regulatory Affairs.
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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As the Director of Congressional Affairs, you will work closely with the Senior Vice President for Federal Affairs to ensure that City Year/Voices for National Service is a highly visible, trusted, and influential resource on Capitol Hill and with the Executive Branch.
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Minimum of 10 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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C. The Dean of Instruction coordinates most closely with the Vice President for Academic Affairs and Student Services, Dean of Academic Innovation and Instructional Technology, Dean of Planning and Institutional Effectiveness (PIE), Dean of Workforce Solutions and Continuing Education (WSCE), Dean of Student Affairs, the Vice President for Administration and Finance, the Senior Director of Information Technology, and the Academic Division Directors.
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Guidehouse is seeking a Project Manager to support the Bureau of Consular Affairs as it designs and implements a Transformation and Change Management function reporting directly to the Consular Affairs Front Office and Assistant Secretary.
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Position Overview QinetiQ U.S. seeks a junior Strategic Communications and Public Affairs Analyst responsible for managing an integrated marketing communications and public affairs portfolio on behalf of a federal law enforcement organization within the U.S. Department of Homeland Security.
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This position presents an opportunity to work with the Associate Dean of Student Affairs to build upon the early stages of our academic skills program to further support our student population.
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Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals.
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Develop and implement project outreach plans, outreach budgets and other materials in coordination with PSEG Long Island External Affairs Regional Managers and other internal groups as appropriate.
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affairs job Title: regulatory affairs project manager Company: Stryker Corporation
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