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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. 15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance.
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Role: OFSAA Technical LeadTechno Functional expertise on OFSAA FCCM suite of productsExperience in the data flow within OFSAA AML, KYC, ECMKnowledge on OFSAA CTR (Current Transaction Reporting) and CRR (Customer Regulatory Reporting)Experience in PL/SQLExperience in Oracle OJET, Oracle Forms Framework, HTML, CSS, JavaScript, and Shell script.
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The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
$80,000 - $90,000RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Regulatory Affairs Specialist. Experience of medical device, SaMD development, or regulatory affairs is preferred. Assist in post-market surveillance activities, such as complaint handling and vigilance reporting Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance.
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Senior director, clinical program lead, late-stage clinical development, clinical trials, global, strategy, hematology, lymphoma, oncology, targeted therapies, ADCs, antibody-drug conjugates, program, asset, label extension, life-cycle management, pharma, biotech, biopharma, MD, medical doctor, phase I, phase II, phase III, FDA.
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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ARM will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates.
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Knowledge of mechanical/thermals (cooling devices, air flow, temp, power, cooling, mechanical design) with electrical/power (power distribution, AC power types, power calculations, DC power, regulatory/safety) is a plus.
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The Master of Public Administration (MPA) program is housed in the Political Science Department and is an accredited member of the Network of Schools of Public Policy, Affairs, and Administration ( NASPAA.
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At least 5 years of experience in the medical device IVD industry, with a strong understanding of FDA regulatory standards and compliance requirements. The ideal candidate will have a minimum of 5 years of technical lead experience in the medical device field and at least 7 years of experience in data engineering.
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People: We have transitioned thousands of officers into successful careers in law enforcement, government services, foreign affairs and many more. About Inter-Con Security Passion: Joining the Inter-Con family is an opportunity for growth in an environment that truly cares for its employees.
$23.95 - $24 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is part of Clinical Affairs team and will be hybrid to Sunnyvale, CA. The senior clinical research scientist will work on advanced, complex projects requiring state of the art knowledge in oncology and/or infectious disease molecular diagnostics.
$103,000 - $142,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The right candidate will have a basic understanding of and enthusiastic belief in the cryptocurrency/digital asset space, 5+ 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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Ensure compliance with industry standards and regulatory requirements (e.g., PCI-DSS, GDPR) We are looking for a highly technical Sr. Network Engineer who can lead people and projects to join our driven NetOps team.
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regulatory affairs jobs Title: director clinical lead in Santa Clara, CA
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