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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Janssen Research & Development , L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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The Regulatory Specialist will serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies.
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At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable.
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The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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This position reports to the Functional Area Head, Global Regulatory Affairs. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs Team for Alliance compounds) and as a subject matter expert (SME), in alignment with the GMAT Lead, develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment, gap prioritization and strategic delivery plan.
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Regulatory Affairs Specialist Project Lead I. At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global.
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Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations. They will serve as a system administrator for BPI's US Regulatory electronic document management system and as the primary publisher of US Regulatory submissions.
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4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA considered a plus. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA, supplements, annual reports as well as the rapid and efficient turnaround of time-sensitive submissions.
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This exciting Regulatory Affairs Associate role reports to the Group Director and will have extensive coordination with different team managers and specialists in a friendly and collaborative environment.
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EEC. Regulatory Affairs Certified RAC (RAPS). Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business.
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7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Experience in providing regulatory strategic input into the Oncology drug development preferred.
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Title: regulatory affairs Company: Gritstone Oncology in Warren, NJ
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