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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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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.
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Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The incumbent is responsible for analyzing PGW regulatory compliance in communications and actions from regulators and ensuring operating practices are in accordance with local, Commonwealth and federal regulations and requirements.
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Experience in Business or System Administrator is a plusExperience with managing vendors/consultants/partners (e.g. external publishing vendor)Strong understanding of Regulatory Operation comprehensive roleDesirablePrior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferredExperience with BLAs/NDAs/MAAs preferredExpertise in Veeva RIM, system implementation experience a plus.
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This role will work closely with members of B. Braun’s international regulatory, quality, legal and compliance teams ,to drive overall global strategy, improvements and risk mitigation, and other key initiatives.
$157,000 - $204,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Job Summary:The Senior Associate is responsible for performing analysis, examination, review, assessment, and testing in a wide variety of client engagements at the direction of the project manager.
$80,000 - $100,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy) The Quality Assurance Analysis will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufactured at our facility.
$37,220 - $65,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Join Takeda as a Director, Precision Medicine and Digital Health where you will be responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital health tools to enhance the value of our products across therapeutic areas.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Proactively identify, mitigate, and track recurring regulatory issues. They will work to ensure the organization complies with regulatory requirements and ethical standards, as well as contractual obligations, and that company policies and procedures reflect applicable regulatory requirements and contractual obligations.
$65,600 - $70,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As a key stakeholder, the Director represents the investigator/research team when working with internal regulatory groups such as the IRB, OCR, Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), Data Safety and Monitoring Committee (DSMC), and DOCM, as well as external entities including pharmaceutical companies, contract research organizations, the FDA, and the NCI’s National Clinical Trials Network (NCTN) groups.
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This role will report to Arcadium Lithium’s Associate General Counsel and will serve as primary legal counsel to the company’s Global Finance team and will support global regulatory compliance activities.
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Biology), with 10+ years of relevant experience or a PhD with 4-6 years of relevant experience Must have demonstrated expertise in global, biologics regulatory CMC Sound understanding of molecular biology and cell culture.
$187,100 - $280,700 a yearFull-timeExpandApply NowActive JobUpdated Today
Title: regulatory Company: Clarivate Plc in Philadelphia, PA
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