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Author regulatory submissions and serve as a pharmacokinetics/clinical pharmacology subject matter expert during interactions with regulatory agencies. As a Pharmacokinetics/Clinical Pharmacology Principal Scientist, you will utilize your experience to further characterize the novel kinetics of our new therapeutic modality and build complex models that inform study designs and decision-making throughout the drug development process.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We are looking for an experienced and innovative credit attorney to join our product and regulatory counsel team as Senior Counsel, reporting to the Deputy General Counsel and VP, Regulatory & Product at Robinhood.
$210,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Manage Legal’s support of key aspects of our privacy compliance programs and processes to ensure we meet our obligations under those programs and applicable regulatory frameworks. Experience with compliance, regulatory, or product counseling.
$233,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advocacy skills before regulatory bodies such as the DOJ and FTC.Ability to handle antitrust matters in technology, life sciences, and private equity sectors. Advocating on behalf of clients before regulatory bodies such as the Department of Justice (DOJ) and Federal Trade Commission (FTC.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
$247,610ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, cell therapy manufacturing, clinical pharmacology and pharmaceutical sciences) Must be able to collaborate and work with other departments such as ClinOps, Safety, Translational, Biometrics, Regulatory, Commercial, Finance, Manufacturing, and Supply Chain.
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In order to be effective you will apply radiation detection principles, knowledge of regulatory requirements and proficiency in one or more of the following areas: radioactive material activation and contamination surveys, shipping determinations, area radiation monitoring, radiological work control development, gamma spectroscopy and liquid scintillation.
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Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
$309,140 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Prepare and provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (, IB, DSUR, PSUR, regulatory responses)Participate or lead as needed the review and assessment of new opportunities and ESRs. Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
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The Sr. Director, Clinical Development will work closely with individuals in other functional areas (e.g., clinical operations, regulatory, preclinical, project management, quality, CMC, etc.) Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook) and extensive experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Head of Legal will report to the CEO and be responsible for providing legal counsel and support to Orca Bio on a wide range of matters, including corporate governance, strategic and financing transactions, contract operations and review, clinical trials, employment, regulatory compliance, and commercial preparedness.
$250,000 a yearExpandApply NowActive JobUpdated 15 days ago
regulatory job Title: pharmacy tech Company: Abrazo Health in San Mateo, CA
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