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Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency.
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Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. If so, this Director, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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You will provide support across all of Regulatory including Operations, Strategy and CMC. This role will provide project management of multiple Regulatory workstreams. Understanding of drug development and regulatory requirements (standards, quality, timeliness.
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We are seeking individuals who are interested in working on our Nuclear Regulatory Commission contract, please apply to this posting. Tier I NOC Technician. Release and Deployment SCCM Engineer.
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Regulatory Affairs Manager. Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDregulated environment is desirable.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Performing vaccine and/or biologics regulatory submissions.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Prior regulatory experience with infectious disease & vaccine development preferred. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU.
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Train and mentor other attorneys, regulatory analysts, legal assistants, and administrative assistants in OGC.Education/Experience Requirements:Law degree from an accredited law school, admission to a bar, and a minimum of 6 – 8 years of directly related legal experience.
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Regulatory Health Consultant. Support the regulatory health portfolio on projects, including medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program evaluation, and project management.
$137,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Previous demonstrated experience of regulatory drug development including product approval/launch. The Senior Regulatory Affairs Director (SRAD) responsible for oncology paediatric regulatory strategy (OPRS) serves as the regulatory representative on the AZ Paediatric Oncology Development Team (PODT) developing global paediatric strategies and studies across the entire oncology portfolio.
$311,488 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC Size. Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC Size. Import video from YouTube or Vimeo Copy / Paste your video page and import it to your library.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Work closely with Regulatory Operations to ensure on-time submission of required documents. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Provide critical regulatory review of promotional and non-promotional external communications.
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HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of MCCRP research protocols with applicable local, state, and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Support a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc.
$100,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 14 days ago
Title: regulatory Company: Impact Legal Resources in Rockville, MD
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