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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI. The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective.
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Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization.
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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Work in close collaboration on safety issues with the Director of Drug Safety and colleagues from Regulatory Affairs, Medical Affairs, Data Management, and Clinical Operations. Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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Works cross-functionally with other internal groups (eg, Clinical Operations, Biometrics, Data Management, Pharmacovigilance & Drug Safety, Translational Medicine, Preclinical Science, Regulatory Affairs, Medical Affairs, Business Development, and New Product Planning.
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This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection.
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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regulatory affairs jobs Title: intern Company: Alcorn State University in Waltham, MA
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