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Provide legal counsel and guidance to clients on FDA regulatory matters related to regulated products. 5-10 years of experience in FDA regulatory law, preferably with a focus on counseling companies with FDregulated products.
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A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel to join their team in Washington, DC. The ideal candidate will provide comprehensive legal counsel on FDA regulation matters pertaining to drugs, biologics, cellular, and gene therapy products.
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Job Overview: A law firm in Washington, D.C., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters.
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FDA/CFSAN seeks expertise in vibrational spectroscopy (IR, NIR, Raman), GC-MS, LC-MS, HR-MS, LC-UV, and/or ICP-MS for an applied research position. FDA/CFSAN seeks expertise in GCxGC, LC-GC, LC-UV, LC-MS, HR-MS, ICP-MS, and/or non-targeted analysis for an applied research postdoctoral fellowship.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Internationally, the position works cross-functionally with Logistics and Quality Assurance at Oticon Medical's suppliers to ensure that product labeling is consistent with FDA approvals. Establishes and maintains registration and licensing of Oticon Medical LLC per Federal (e.g., FURLs FDA site), State and Local guidelines for the scope of activities in which the company is engaged.
Part-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards. In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11 and ICH guidelines.
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About The Chefs' Warehouse
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Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems. Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
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Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the pharmaceutical/biologics industry.
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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA. Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
$118,000 - $147,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
$173,700 - $208,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Relevant experience working in a food manufacturing environment with USDA and FDA manufacturing preferred. Working with USDA, FDA, SQF a plus. Our well-known banners include Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Kings Food Markets, and Balducci's Food Lovers Market.
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Monitor SPD staff compliance to Salem Health and regulatory standards (IAHCSMM, TJC, OSHA, CDC, FDA, AAMI, AORN, etc. Monitor SPD staff compliance to Salem Health and regulatory standards (IAHCSMM, TJC, OSHA, CDC, FDA, AAMI, AORN, etc.
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Experience working in a food processing environment and familiar with USDA, FDA, and SQF policies and procedures. Experience with the use of condition diagnostic techniques including vibration analysis, oil analysis, ultrasonic testing, and thermographic testing.
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