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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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Evaluate various regulatory mechanisms to optimize product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans, diversity action plans) and ensure that they are implemented, if applicable.
$206,250 a yearExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Sr. OnBase Developer. Experience in the configuration and setup of ECM document imaging, document management, document import processing, workflow, electronic forms (html, unity) and reporting modules.
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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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The Manufacturing Associate III is responsible for advising and supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to perform operational, as well as routine tasks in the production of cell therapy and/or human cells cultivation.
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As a Tax Senior Manager within the Global Information Reporting practice, you will be part of a diverse team that is currently leading the transformation and digitalization of the tax profession in the area of international tax transparency for the financial industry.
$119,490 - $272,090 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate will and work closely with product, marketing and compliance groups and FINRA staff to help ensure regulatory compliance of marketing and sales collateral, digital content, and market commentary.
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The primary mission of the Consumer Insights Associate Director GCB Home is to design and implement methodologies, analytical tools and deployment platforms for key global home care clients in in North America.
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Solid experience with Compliance (Regulatory and Industry) and Security frameworks. At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
$114,375 - $190,625 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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State Street Alternative Investment Services (AIS) provides fund accounting, administration, tax, compliance and middle office trade support services to hedge fund managers.
$50,000 - $83,750 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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State Street Alternative Investment Services (AIS) provides fund accounting, administration, tax, compliance and middle office trade support services to hedge fund managers.
$50,000 - $83,750 a yearFull-timeExpandApply NowActive JobUpdated Today - 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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The Valuation Senior Associate can be based out of any of our U.S. office locations (New York, NY; Philadelphia, PA; Boston, MA; Braintree, MA; Woburn, MA; Princeton, NJ; Whippany, NJ; East Brunswick NJ; Red Bank, NJ; Saddle Brook, NJ; Providence, RI; Baltimore, MD; Bethesda, MD; Nashville, TN; Boca Raton, FL; Orlando, FL; San Diego, CA; Los Angeles, CA; Orange County, CA; San Francisco, CA; San Ramon, CA; Portland, OR; Seattle, WA.
$80,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As an Associate Director, Translational Medicine, you will support activities related to design, execution and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and execution of early phase trials and biomarker plans.
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Provide project strategy, oversight and direction for regulatory compliance, environmental permitting and land use projects. Ramboll is seeking a highly motivated Manager to lead projects and tasks primarily in regulatory compliance and land use permitting.
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Title: sr regulatory associate Company: Thermo Fisher Scientific in Princeton, NJ
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