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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements. Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
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Basic Qualifications:Bachelor's DegreeExperience of all phases of the drug development process in Regulatory Affairs preferredKnowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
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The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements.
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Head of Regulatory Affairs - Permanent - Fully remote. Proclinical is seeking a Head of Regulatory Affairs to lead strategic regulatory decisions for an innovative biotech portfolio.
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Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC. Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC.
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4+ years of experience in regulatory affairs, product development, research & development, clinical research. An Auditing Organization recognized by the MDSAP Regulatory Authority Council.
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The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements.
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Collaboration: Work closely with cross-functional teams, including Quality Assurance, Process Development, and Regulatory Affairs, to support project goals. Quality Control: Conduct in-process testing and quality checks to ensure compliance with regulatory standards and company policies.
$33 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience of all phases of the drug development process in Regulatory Affairs preferred. Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan.
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Experience with rent stabilization and landlord-tenant affairs laws, regulations, and policies. Department of Housing and Community Affairs (DHCA) w orks to preserve and increase the supply of affordable housing; maintain existing housing in a safe and sanitary condition; preserve the safety and quality of residential and commercial areas; ensure fair and equitable relations between landlords and tenants; and support the success of common ownership communities – all with a focus on reducing racial inequities and climate change impacts.
$167,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health.
$72,800 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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For Company-Sponsored Trials, collaborate and assist Clinical and Regulatory Affairs in reviewing study sites, identify potential investigators to participate in clinical development programs, identify barriers to patient enrollment and retention efforts to achieve study milestones, address questions from investigators and provide information regarding participation in company-sponsored clinical studies.
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Typically minimum of ten years relevant engineering, project management, and/or licensing/regulatory affairs experience. Experience leading licensing/regulatory affairs teams in achieving regulatory outcomes (i.e., safety evaluations, design approval/certification, license issuance) including experience managing interactions with expert advisory committees or equivalents.
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The departments you will work with starting out is the QA, VP of Clinical and regulatory affairs, VP of Global tech sciences, Project coordinator, and Director of Business Development/CMO PM. As well as working with our commercial consulting company.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago
regulatory affairs jobs in Rockville, Lahaina, Hawaii
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