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The Director, Regulatory Operations is accountable for supportingAvidity RAobjectivesbysupporting and managing regulatory submission-related activities and providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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The Senior Regulatory Affairs Specialist leads regulatory compliance objectives for the Invivoscribe family of companies, with the main focus being that regulatory submission projects are completed on time and that related technical documentation files are maintained.
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Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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In collaboration with AbbVie About The Role Addresses a broad array of legal matters to support the Company’s Commercial, Corporate Affairs, IT, Research, Development, Clinical, Regulatory, Manufacturing, Medical Affairs, Business Development, Alliance Management and/or general administrative departments.
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The Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
$155,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborating closely with the Clinical Operations Team, Regulatory Affairs & CMC functions to provide expert quality assurance information, address identified issues, and drive continuous improvement.
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Provide operational expertise to internal and external teams (CMC, regulatory affairs, non-clinical, medical writing, data sciences, drug safety, CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met.
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An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
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Support cross-functional launch teams, including marketing, sales, medical affairs, patient advocacy, regulatory, manufacturing, and supply chain, to ensure successful product launches. Strong understanding of drug development, regulatory, reimbursement requirements, and commercialization processes.
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8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. Minimum of 5 years in regulatory affairs or regulatory operations experience.
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Medical Device - Regulatory Affairs Manager - (Hybrid in San Diego) Our client, an established and still growing medical device company based in San Diego, is seeking an experienced and dedicated Regulatory Affairs Manager to join their dynamic team.
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The Manager, Regulatory Affairs CMC will be responsible for CMC regulatory submissions including US IND applications, amendments to INDs, IMPDs, DSURs, and annual reports, ensuring submissions are high quality and submitted on time.
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The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ORIC. This involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members.
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Minimum of 10 years of experience in Clinical Regulatory Affairs within drug development. We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team.
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The Regulatory Affairs Specialist will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.
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regulatory affairs jobs in San Diego, Lahaina, Hawaii
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