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Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
$295,290 - $382,140ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$177,905 - $230,230Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ability to interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, clinical development, statistics, regulatory, publications, as they relate to on-going medical affairs projects.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience working with external contractors supporting the work of regulatory affairs is a plus. Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Closely collaborates with various internal stakeholders such as Clinical Operations, Clinical Sciences, Regulatory Affairs, Biostatistics, Data Management, and Project Management, as well as external partners to ensure execution of pharmacovigilance activities in accordance with relevant regulatory requirements.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs (regulatory submissions, Health Registration Management, etc.) Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.
$82,800 - $136,600 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Employment is with BMO Harris Bank, however, in accordance with regulatory requirements, LPL Financial would hold your securities/insurance licenses. This employment opportunity at BMO Harris Bank in Palo Alto, CA would allow you to join the Investment Program at BMO Harris Bank as a Financial Advisor associated with LPL Financial.
$70,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with internal customers (e.g. scientists, medical affairs, clinical development, reimbursement, regulatory, operations, business development and sales/marketing) to build customer and product requirements for Guardant CGDB-based portfolio.
$131,040 - $253,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with partners in Process Development, Regulatory, and Clinical groups to fulfill company objectives (Tech Transfer, IND filings, IP) Experience with multi-color flow cytometry, panel design, primary cell culture, cell sorting and/or data analysis is preferred.
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Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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Ensures the delivery of safe, quality patient care in alignment with hospital policies and applicable state/federal regulatory requirements (such as CMS, OPTN/UNOS, and TJC). Works closely with members of the Stanford Health Care leadership team to support clinical, quality, regulatory compliance, information systems, fiscal, and research goals and initiatives of the program(s.
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partners with the chair and other faculty to manage the financial and administrative areas of the department to include grant management, faculty and academic affairs, student affairs, external relations, and human resources.
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Foster City, CA
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