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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. ·Identify and refer to community services, as indicated·Accesses and navigates the EMR to obtain essential information and documents CMRS progress notes and Resource Specialist Quick Notes per department standards.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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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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International student and scholar tax workshop(s) Supervision and training of: 3-4 full-time employees Graduate interns (1-2 per semester) 7-9 undergraduate and graduate student workers, often multiple at a time Temp or part-time staff brought on during busy time Other Duties Responsible for issuing international student statistics and Open Doors report.
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Minimum 1+ years speech therapy experience required.
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Certified Anti-Money Laundering Specialist (CAMS), Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is responsible for executing model risk management activities consistent with the framework, industry best-practice and regulatory guidance.
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MINIMUM ENTRANCE REQUIREMENTS: Applicants must have at least (A) two years of full-time, or equivalent part-time, paraprofessional experience in legal research or legal assistant work, or (B) any equivalent combination of the required experience and the substitutions below.
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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
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Sr. Project Manager, Construction page is loaded Sr. Project Manager, Construction Apply locations Concord, NH USA Atlanta, GA Philadelphia, PA Oakbrook, IL USA Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id R015652.
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10+ years of work experience in pharmaceutical/biotech regulatory affairs, with at least 8 years of Regulatory Operations experience. We are now looking to add capabilities in the Regulatory function and seeking to therefore hire a Director, Regulatory Operations , to join our Regulatory Affairs team and report to our Vice President, Head of Regulatory Affairs & Quality.
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regulatory affairs specialist full time jobs in Cambridge, MA
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