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4-6 years of experience in FDA regulatory compliance, preferably in a law firm or corporate setting. Duties:Provide legal advice and support on FDA regulatory matters related to drug and medical device compliance.
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Opportunities are available in our Boston, New York, Palo Alto, San Diego, San Francisco, Washington D.C., and Los Angeles offices.
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The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, manufacturing activities, field corrective actions, and labeling requirements.
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The Office of Cellular Therapy and Human Tissue (OCTHT) within the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) at FDA is recruiting Staff Fellows to serve as researcher-reviewers in the Tumor Vaccines and Biotechnology Branch (TVBB) and the Cellular and Tissue Therapy Branch (CTTB) within OCTHT.
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Coordinates with investigators and study team members to ensure stipulations from approving bodies (Scientific Review Committee, FDA, Institutional Review Board (IRB) and Radiation Safety Committee (RSC.
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Familiarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects research.
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Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits. Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship.
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Working knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is required. Working knowledge of methods and immunoassay technologies used for large molecules (biologics) analysis, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc.
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The AGC's areas of primary responsibilities include:Marketing, Labeling and Advertising: Provide legal advice and risk management counseling on a variety of legal issues, including label claims, packaging, FDA and FTC compliance; review media and advertising for legal compliance and risk management.
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Previous experience working and/or collaborating with researchers from federal government agencies whose mission relates to public health (e.g., NIH, CDC, FDA, HRSA, or other HHS agencies). And if that isn't amazing enough, ICA has established itself as a critical partner of the US Food and Drug Administration (FDA.
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A new metro train line connects the campus to the Capital Mall. This unique proximity to business and technology leaders, federal departments and agencies (USDA Beltsville, FDA, APHIS, NIH, NSF and NOAA among others), and a myriad of research entities, embassies, think tanks, cultural centers, and non-profit organizations is simply unparalleled.
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Manage data streams from study proposal, through all assay and general lab procedures, to analysis and reporting in compliance with data integrity best practices and FDA title 21 part 11. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
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Experience delivering infrastructure services in support of Health and Human Services (HHS) operating divisions, including National Institutes of Health (NIH), Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA.
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Broad and detailed understanding of FDA regulations related to OTC medicines, consumer medical devices and dietary supplements. ● Works with and communicates with FDA staff regarding OTC monograph ingredients, providing updates to members.
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The advocacy efforts will be focused on Congress and key federal departments and agencies, including the EPA, Dept. of Energy, FDA, and HHS to name a few. Ecolab, the global leader in water, hygiene and infection prevention solutions and services, is seeking a Director of Federal Government Relations based in Washington, DC.Government Relations (GR) is responsible for the strategic direction of Ecolab's global government relations and advocacy efforts.
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fda job in Silver Spring, MD
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