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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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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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Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Serves as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.
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The Regulatory Affairs Project Manager is an experienced project manager who works closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and international health authorities.
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Accomplished policy advocacy professional with at least 15 years of experience in public affairs (government affairs and/or policy). Lead development and implementation of global policy advocacy strategy on key global policy topics including engagement with multilateral institutions, international trade association engagement, and LOCs in close collaboration with Takeda’s Enterprise Public Affairs Leadership Team (EPALT.
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The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence in the planning, preparation, and delivery of regulatory submissions.
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Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG.
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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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The position reports to the Executive Director, Regulatory Affairs CMC. Associate Director, Regulatory Affairs CMC. Minimum of 7 years of experience in the biotech/pharmaceutical industry with a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.
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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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The Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
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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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Title: regulatory affairs Company: Turnstone Biologics in Lexington, MA
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