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The majority of the work is regulatory focused, therefore, our Senior Research Analysts also generate evidence for submission to federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with occasional interaction with other international regulators.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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Understands regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) Lead the statistical programming activities for regulatory submissions following CDISC standards.
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Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing. Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly corporate policy and procedures, and local procedures to maintain product quality and safety.
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At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) The Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system.
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The ideal candidate will possess a firm understanding of applicable laws and regulations and have extensive experience working with key regulatory bodies, including the FDA, USDA, FTC, CPSC, TTB, CPB, DOJ, and other Congressional committees.
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Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
$144,000 - $162,000 a yearExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Are properly labeled Assists and participates in internal and 3rd party audits of SQF and FDA systems to help ensure compliance Reports all food safety/sanitation issues to the Production and QA Supervisor Routinely collaborates with co-workers to ensure daily compliance in sanitation and help ensure guidelines are followed throughout the plant Operate all required Material Handling Equipment.
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The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
$155,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reviews and provides in-depth regulatory compliance recommendations for all NHG marketing materials including ads, flyers, brochures, consumer reviews, and other published product literature to ensure compliance with FDA DSHEA regulations and FTC guidelines.
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FDA, United Nations, Hazardous material packaging and SFC and SFI. The candidate must be able to be a leader in the their role while developing and implementing Quality Management systems, quality assurance initiatives, ensuring product quality, managing supplier quality, provide training and development while also ensuring regulatory compliance.
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Bachelor’s degree in a relevant field, such as business administration, legal studies, or regulatory affairs. Stay updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelines.
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Accountable for maintaining area of operation in compliance with cGMP requirements, cUSP requirements (as appropriate), environmental health and safety policies, and all governmental regulatory requirements for the biopharmaceutical and plasma derived blood products industry.
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Authors, reviews and finalizes the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
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To Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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