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Maintain working knowledge of the policies and procedures of the Human Research Protections Program HRPP and of the VA Human Subjects Office review these policies and procedures under the general supervision of the Medical Director of Regulatory Affairs and as needed, consult with HRPP analysts and the CTO Quality Assurance Manager to resolve issues.
$34 - $55 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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They will also be responsible ensuring strong cross-functional alignment in the flawless execution of strategy and promotional tactics working in close collaboration with partners, especially Patient Services, Patient Advocacy, Corporate Communications, Marketing Operations, Sales Training, Market Research, Regulatory, Legal, Medical Affairs, Regional Marketing Managers, Managed Markets, Regulatory other members of the brand team, and agencies.
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Education & Experience Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
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Technical team (Mechanical, Process, Electrical, Software, and Automation Engineering), Manufacturing, Contract Manufacturing, Procurement, Master Planning, Logistics/Distribution, Facilities, EH&S and others (Regulatory Affairs, Ops Quality, Finance, IT, etc.
$214,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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2+ years of experience in regulatory affairs in the biotechnology industry. Prepare post-market surveillance reports, adverse event reports, and other regulatory reports. Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
$80,000 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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This role will report directly to the head of Quality Assurance / Regulatory Affairs. Work closely with various functions to ensure the documentation complies with all applicable regulatory requirements.
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ROLE RESPONSIBILITIESSupport medical congress strategy and provide subject matter guidance to TA/asset level teams in Medical Affairs, ensuring effective planning and execution of conferences and Ad Boards.
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Over 10 years of experience in the pharmaceutical/biotechnology sector, primarily in Regulatory Affairs. In-depth understanding of global pharmaceutical drug development and regulatory frameworks, particularly with the FDA.
$300,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs.
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Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Biostatistics, to support the successful execution of clinical development programs.
$180,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Maintain Regulatory Affairs archives with current product information (applications, letters, etc.) As the Manager of Regulatory Affairs, you will be responsible for ensuring compliance with regulatory standards while strategically guiding the development and maintenance of regulatory strategies for our marketed product and diverse pipeline.
$158,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Executive Director, Clinical and Medical Affairs, reporting to our Chief Medical Officer (CMO), leads all related activities for assigned partner products and proprietary products and will deputize for the CMO as needed.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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They are looking to bring in an experienced Head of Regulatory Affairs. As they enter late-stages of development it is key for them to find a Regulatory expert who can lead Health Authority interactions and help take these products to market.
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regulatory affairs jobs in San Diego, Beltsville, District Of Columbia
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