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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$284,375 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based in Plainsboro, New Jersey. Essential Functions General All fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or at a key conference/congress.
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Stays up to date and compliant with the regulatory landscape related to drug safety and data analyses. Minimum of - years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
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Under the leadership of Regulatory Affairs, the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, Inc. (TOI) projects, provides strategic regulatory operational guidance during drug development, approval, post-approval, and commercialization, in coordination with internal staff and external consultants/contractors.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Validate and QC of incoming and outgoing regulatory data/documents.
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Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
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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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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.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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Senior Associate, Regulatory Affairs, Dietary Supplements. The Senior Associate, Regulatory Affairs is responsible for developing regulatory strategy and providing guidance to product development and commercial teams in support of Kenvue’s Dietary Supplement Portfolio.
$152,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Assist with the development of assigned regulatory operations work instructions. Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system.
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Minimum of 3-5 years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry. The Associate will leverage a variety of analytics and visualization techniques to contribute to research, clinical development, drug safety and post-marketing activities.
$72.79 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Job Title: Senior Regulatory Affairs Specialist. Certifications: RAC (Regulatory Affairs Certification) from the Regulatory Affairs Professionals Society is preferred but not required.
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Role : Senior Regulatory Affairs Specialist. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Identify opportunity for regulatory affair processes and drive changes to completion.
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Title: regulatory affairs in Lawrence, NJ
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