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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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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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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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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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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. This role is crucial in ensuring that all CMC aspects of drug development meet regulatory requirements globally, supporting Scorpion Therapeutics' mission to bring transformative oncology therapies to patients.
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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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An advanced clinical degree (MD, DO, PhD, PharmD) and a minimum of 3 years in medical affairs or a related field. We are looking for a dynamic Director of Medical Affairs with a passion for medical communication and supporting scientific partnerships.
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15+ years' experience in Regulatory Affairs and Quality Assurance with 10+ years of leadership experience. Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the Regulatory Affairs group, including hiring, mentoring, and leading staff.
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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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Title: regulatory affairs Company: Gritstone Oncology in Woburn, MA
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