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Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives. Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines.
$150ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging clinical-stage programs.
$200InternExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations.
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Operational management of clinical and non-clinical departments including but not limited to: Nursing, Admissions, Business Development, Process Improvement, Finance, Clinical Services, Regulatory Affairs that effectively drive patient care outcomes.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is part of the Quality Assurance and Regulatory Affairs group located in Coralville , IA, USA and will be remote. Join a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc.
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Working in collaboration with the Associate Dean of Academic and Student Affairs, Program Directors, and other student services faculty and staff, the Senior Academic Coordinator will coordinate academic initiatives and programs to meet academic degree, accreditation, and regulatory requirements.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs and other local and headquarter departments to accomplish company goals. Report to a Director of Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Their areas of practice include appellate, automotive, insurance, gaming, class action, government affairs, labor and employment, family law, corporate, bankruptcy, real estate, and much more. Firm Type: Law Firm, Experience: 5 Years, Job Overview: A law firm in Lexington, KY, is seeking a Senior-Level Healthcare Associate Attorney with 5+ years of experience in healthcare regulatory and transactional matters, including mergers and acquisitions.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Significant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transfer. Participate in all plant activities to ensure cGMP-compliant manufacturing and regulatory inspection readiness.
ExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Assure compliance with all company SOPs, directives, policies, testing requirements, and regulatory agency guidelines and expectations. Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations.
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The Director of Enterprise Regulatory Affairs will oversee and assure continued accreditation for the UK HealthCare Enterprise, coordinating and directing efforts related to The Joint Commission ( TJC ) , Office of Inspector General ( OIG ), and Centers for Medicare & Medicaid Services ( CMS.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
Full-timeExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
$149,100 - $234,300 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Requires a minimum of 10 years of experience in Regulatory Affairs within the bio pharmaceutical industry. Provide leadership, and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities worldwide in support of INDs, BLAs, MAAs, DMFs, CTRs/CTAs, IMPDs, PIPs, PAERs, amendments, safety reports, and annual updates.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Provide regulatory strategic leadership for drug development projects and life cycle management (LCM), including but not limited, to regulatory submissions to EMA and other Health Authorities worldwide, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines.
ExpandApply NowActive JobUpdated 26 days ago
regulatory affairs jobs in Lexington, Missouri-city, Missouri
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