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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. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
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Utilizing the nursing process, the ECT/TMS/Ketamine nurse is responsible for providing for immediate and long-term nursing care needs of patients receiving ECT/TMS/Ketamine within the standards of the department, hospital and regulatory agencies.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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The Privacy Officer oversee data privacy and protection policies to ensure that the entire organization processes the personal data of their customers, employees, and partners, in accordance with company policies and regulatory compliance requirements.
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Global health regulatory agency knowledge and experience across GxP life cycle in Cell & Gene therapy and/or Biologics. The role will be responsible for supporting the development of the cell therapy quality strategy to meet business, regulatory, and operational requirements.
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Therapeutic Area Expertise: Provide clinical safety and pharmacovigilance support for Apnimed’s developmental products, collaborating closely with Clinical, Safety, Regulatory, Pharmacovigilance, Data Management, and Biostatistics/Programming teams.
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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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Experience in end-to-end CMC drug development from early to late-stage development, GMP clinical and commercial operations and regulatory submissions. Proficient in GMP, GLP and regulatory guidelines related to pharmaceutical development.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Responsible for psychosocial assessments and interventions in crisis situations that often involve issues of suicide, homicide, family violence, elder or child abuse.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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O Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Understanding of regulatory requirements for cell therapy manufacturing and GMP processes is a plus. Use understanding of regulatory requirements to guide data collection and storage practices.
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Strong understanding of vaccine-specific drug development and regulatory pathways, payer reimbursement models, and health policy across multiple regions, with the ability to adapt strategies to different global markets.
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MedInsight is a subsidiary of Milliman; a global, employee-owned consultancy providing actuarial consulting, retirement funding and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as well as a range of other consulting and technology solutions.
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Textron Systems Slidell, LA, or Wilmington, MA (Land, Sea, Weapons, and Howe & Howe) is seeking an experienced Export Compliance professional to manage our expanding regulatory compliance and contractual obligations in our defense line of business.
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