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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
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Enforce the rules of the university by working in partnership with the Dean of Student Affairs Office and provide written and oral documentation of violations. The Tufts University Department of Public Safety is comprised of fully sworn and certified police officers, campus security officers, dispatchers, emergency management, fire safety, crisis intervention, threat assessment staff and a student run EMS service.
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This includes: an industry-leading dispatch management platform powered by Swoop; comprehensive accident management services; knowledgeable consumer affairs and connected vehicle capabilities; and a growing marketplace of services, discounts and support enabled by a robust partner ecosystem.
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Lead and strengthen coordination and alignment of priorities and information sharing between OCPA and leadership and communications/marketing staff in Professional and Lifelong Learning (Executive Education & Public Leadership Credential), Degree Programs and Student Affairs, and Alumni Relations and Resource Development.
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Preferred Qualifications: Master's degree in Communications, Public Affairs, Renewable Energy, Community Development, or a related field. What you'll bring: Bachelor's degree in Communications, Public Affairs, Public Policy, Business, or a related field.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing. Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS.
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Departments include senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development and medical writing.) Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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Organizational Administration Serves as the principal liaison to other MGB and hospital departments and services such as: Patient Care Services; Network Development; Marketing; Office of General Counsel; Development; Public Affairs and Communications; Research Management; Budget and Finance.
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QualificationsQualifications Bachelor's degree required; Master’s degree in medically-related area preferred (Nurse Practitioner, Physician’s Assistant) Minimum of 3 years of relevant experience in IRB, clinical research and/or regulatory affairs.
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Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.
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The U.S. MSL Team Leader will work under the guidance of the Global Head of Medical Affairs and in close collaboration with the Global Medical Affairs Leads (GMALs), EU Medical Affairs team, Clinical Operations, Clinical Development teams and Patient Advocacy.
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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs.
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affairs job Company: Careerbuilder Us in Burlington, MA
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