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Director, Regulatory Affairs, Rare Disease. Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialisation teams, Public Affairs, Legal,Investor Relations, etc.
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Job Description About This Role The Associate Director, Scientific Communications (Spinal Muscular Atrophy) is a member of the Global Scientific Capabilities department within Medical Affairs and will lead the publication team for our Spinal Muscular Atrophy franchise.
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Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.
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Manager, CMC Regulatory 2031350. 5+ years working in the pharmaceutical industry, and strong experience writing CMC regulatory sections (including IND's/ CTA's) Job Overview: Author and manage process for CMC regulatory documents including module 3 CMC submissions, technical reports and SOPs.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
$18.75 - $19.35 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist or clinical laboratory scientist.
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Maintain a safe work environment and wear appropriate personal protective equipment Requirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.
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The Special Program Coordinator will be an active member of the Student Affairs Division and work closely within the Division with the Student Counseling Center, the campus food pantry (the DISH), Disability Services, Single Stop, Student Engagement and Leadership, Athletics, Veteran Services and other key campus partners.
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Enterprise risk tracking/monitoring and reporting, enterprise risk scorecards and dashboards, ERM Office senior leadership and Board/Audit Committee materials and reports, ORSA and other regulatory reports/submissions (e.g., Form F, climate change risk surveys, Corporate Governance Annual Disclosures, etc.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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Participates in CHW staff meetings, CHW/Student Affairs professional. student affairs emergency response team during times of campus crises. development programs and Student Affairs divisional meetings.
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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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The ideal candidate will have a background in OSHA and EPA regulatory compliance, environmental health & safety program development, risk identification, and compliance auditing. Assist in securing and renewing EHS permits from regulatory agencies.
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Collaborate with cross-functional teams including members from assay development, software engineering, marketing, quality, regulatory, and others to execute complex product development projects.
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The Core laboratory functions include technical, regulatory, and clinical oversight of core laboratory functions of clinical chemistry, point-of-care, laboratory information systems/informatics, mass spectrometry, immunology and routine hematology.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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