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As the VP, CISO, you’ll be the guardian of people, processes, and technology, ensuring regulatory compliance and upholding the confidentiality, integrity, and availability (CIA) of our information and assets.
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This job is responsible for providing operational support and overall coordination for the strategic implementation of licensing and accreditation programs consistent with state and federal rules and regulatory requirements.
$46.96 - $68.1 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The right candidate will have a basic understanding of and enthusiastic belief in the cryptocurrency/digital asset space, 12+ years of relevant litigation and regulatory experience at a top law firm or in-house at a fast-paced, brand-name business, and possess strong academic credentials and excellent writing and analytical skills.
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Develop and lead CMC Regulatory strategies for a portfolio of programs in development, including AAV gene therapies and small molecule drugs. Align CMC regulatory strategy to overall regulatory business strategy (e.g. viral vector upcoming process, raw material, shelf-life and analytical changes.
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Strong working knowledge of Maritime Regulatory Authorities (i.e. ABS, NAVSEA, MIL, USCG, IMO, etc. Ensuring vessel design is in compliance with relevant regulatory authorities, specifications and customer requirements.
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Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory/CMC teams, and developing and implementing complex CMC regulatory strategies.
$234,900 - $290,200 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Work collaboratively with cross-functional members of the Firm’s global Finance & Accounting, Investment Operations, Legal, and Technology departments to ensure effective and efficient operations of the Regulatory Reporting program.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Support the business in connection with its trading activities, including negotiation, drafting and review of necessary contractual documentation, and supporting the company's compliance with regulatory requirements and frameworks applicable to company trading activities, including FERC, RTO/ISO, CFTC, Dodd Frank, environmental and anti-trust requirements.
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In this role you will join a team of program managers, uphold and maintain the Cash App product’s licensing and regulatory obligations, and manage projects and strategic initiatives concerning parties external to Cash App, such as regulators, partners, and consultants.
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Research, specify, design, verify, and validate very low-power analog front-end design and battery-powered embedded systems per applicable regulatory standards for medical devices. Working experience in EMC/EMI design and testing for regulatory standards.
$83,600 - $167,200 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Similar Jobs (5) Director, Regulatory CMC, Cell & Gene Therapy (Boston) locations Boston, MA time type Full time posted on Posted 4 Days Ago External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supply Chain Manager - Cell & Gene Therapy (Hybrid) locations Boston, MA time type Full time posted on Posted 25 Days Ago.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Oversees the administrative, regulatory, and programmatic activities of the Institutional Review Boards ( IRB ); Institutional Animal Care and Use Committee ( IACUC ), Institutional Biosafety Committee ( IBC ), Radiation Safety Committee ( RSC ), Stem Cell Research Oversight Committee ( SCRO ), and Laser safety program.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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regulatory job Company: Metroplus Health Plan
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