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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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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.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The team advises business clients on industry specific issues in the US and Canada including: the Federal Anti-kickback Statute (AKS), the False Claims Act (FCA), HIPAA, Privacy, Marketing and Promotional issues, FDA and Regulatory issues, Compliance issues, Clinical issues, Reimbursement issues, Medicare billing and provider issues, and other federal, state, and Canadian laws applicable to a medical device manufacturer or durable medical equipment supplier.
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The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA. Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies.
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5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree. 5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree.
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Established in 2005, the Fischell Department of Bioengineering is located in the Washington DC–Baltimore metropolitan area proximate to the NIH , NSF , FDA , EPA , NASA and NIST , as well as many other health and medical science-related institutions and agencies, forming a unique and diverse hub of health-related activity.
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The purpose of this FDA guidance is to assist in the clinical trial designs for the development of novel drugs to support indications for treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder," said Dr Vicent Ribas, Prepaire’s Co-Founder.
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Decarbonizing heavy industries requires numerous approaches that can concurrently and collaboratively help mitigate greenhouse gas emissions," said Ricky Sakai, Senior Vice President of New Business Development at MHI of America.
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The Senior Specialist will, under limited supervision, provide a full range of contract and subcontract drafting, review, negotiation and administration services primarily with respect to government customer contracting (civilian agencies such as HHS, (CDC, CMS, NIH, HRSA, SAMHSA, FDA, etc.
$88,000 - $120,000 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Serves as the Serialization Site Lead by providing serialization training and strategy; including providing industry insights and knowledge on DSCSrelated progress; and guidance on GS1 US and HDA serialization data and label standards as well as FDA requirements.
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We expect our employees to comply with all relevant FDA requirements and external certifications (e.g. Kosher, Halal, etc.) Develop and manage key food service brand partnerships as well as relationships with large broadline distributors and redistributors including Sysco, US Foods, Performance Food Group and DOT Foods.
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For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
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Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance.
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GS-09: Your resume must demonstrate at least one (1) year of specialized experience equivalent to at least the next lower grade level in the Federal service obtained in either the private or public sector performing the following type of work and/or tasks: Digital Radiological exams and mammography exams including conducting screening and diagnostic mammography examinations; complying with FDA and ARC mammography standards.
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