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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Associate Director, Global Regulatory Affairs Operations, Authoring Support page is loaded. 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.
$200ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs – Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies.
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Following the Ph. D., 2+ years of mathematical modeling & computer simulation experience in the pharmaceutical industry for the Sr. Research Investigator level or 5+ years for the Associate Director level.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
$90,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This is done in alignment with the Global Medical Affairs and corporate strategy. The Senior Director of Medical Affairs in Oncology provides exceptional medical leadership for creating and implementing medical affairs strategies, plans, and tactics for the current products and pipeline portfolio in Oncology for the North American region.
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As a warehouse associate at Floor & Decor, you are the backbone of our retail location. This policy and the law prohibit employment discrimination against any associate or applicant on the basis of any legally protected status outlined above.
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10 The Role: Sr Data Scientist- NLP, LLM and GenAI. Bachelor's / Master's in Computer Science, Mathematics or Statistics, Computational linguistics, Engineering, or a related field. S&P is a leader in risk management solutions leveraging automation and AI/ML. This role is a unique opportunity for hands-on ML scientists and NLP/Gen AI/ LLM scientists to grow into the next step in their career journey and apply her or his technical expertise in NLP, deep learning, GenAI, and LLMs to drive business value for multiple stakeholders while conducting cutting-edge applied research around LLMs, Gen AI, and related areas.
$100,200 - $185,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Postdoctoral Research Associate PositionsPrinceton Precision Health Initiative @ Princeton University / GFDL @ NOAALewis-Sigler Institute for Integrative GenomicsPrinceton University The Princeton Precision Health Initiative (PPH) at Princeton University was established to transform human health and health policy and improve health equity and outcomes.
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1.1Big Data Support (Exadata, Netezza, ODA, ZFS, GG, DBA)
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Consulting Associate, Corporate Sustainability & Climate Change (Entry Level) Consulting Associate, Geologist/Engineer (Entry Level) Consulting Associate, Climate Change (Entry Level.
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As a Sales Associate, you act as a brand ambassador bringing your own personal style, passion for the product and welcoming energy to the sales floor each day. The base salary is just one component of J.Crew Group's competitive total rewards strategy that also includes the opportunity for bonus, competitive benefits and perks.
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Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Hopewell, NJ
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