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As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. - Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry with at least 5 years in cell therapy.
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The Regulatory Affairs Specialist is responsible for ensuring foreign and domestic compliance for regulated dental products adhering to Quality and Regulatory compliance. Contributes to Regulatory projects and deliverables to ensure Argen remains compliant to MDR and ISO requirements.
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Senior Regulatory Specialist page is loaded. Senior Regulatory Specialist. You will join an existing team of Natural Resources professionals that includes wildlife biologists, botanists, aquatic resource biologists (waters, wetlands, and riparian areas), restoration ecologists, and regulatory specialists.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? Track Federal Energy Regulatory Commission, PJM, State Public Utilities Commission (PUC), and other federal and state agency policies that impact Companys’ business and coordinate with appropriate functional groups within the Company (Development, Power Marketing, Finance, Asset Management) to ensure policy impacts to our business are understood.
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UC San Diego values equity, diversity, and inclusion.
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Demonstrated ability to work in a team environment and with regulatory agency personnel. 5+ years of experience completing project permit applications and supporting documents under the Clean Water Act (Sections 401 and 404), Porter-Cologne Water Quality Control Act, Section 1600 of the State Fish and Game Code, for the Corps, SWRCB/RWQCB, and CDFW.
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Lead a team of stakeholders to develop/implement effective CMC regulatory strategies for submissions (e.g. BLA/MAA) and identify regulatory risk. The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissions.
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The Regulatory Affairs Specialist IV 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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Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials.
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The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps-understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
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We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. Job Title: Regulatory Specialist - IVD and 510(k) The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements.
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The Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. Regulatory Affairs Specialist. Assist in regulatory submissions (510(k), PMA, and CE.
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Arrowhead is seeking an experienced Regulatory/Medical Writer to lead its Medical Writing Team. The Regulatory/Medical Writer will work collaboratively with Arrowhead’s regulatory, clinical and scientific teams to produce high quality documents to support the company’s drug development programs.
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The Manager of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing input on labeling requirements and strategic guidance during label development, assisting the Head of RA Labeling with cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) as appropriate, and label-related Health Authority negotiations.
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Title: regulatory Company: Coda Searchstaffing in San Diego, CA
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