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The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements as well as a proven track record in analytical development for clinical stage and commercial programs.
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Ensure laboratory is compliant with corporate, state and federal regulatory requirements (CAP, CLIA, State, ISO, etc) related to personnel safety and quality of laboratory testing as well as professional conduct.
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10+ years' experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
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As our Senior Business Performance Analyst, at ENGIE’s Medical Area Total Energy Plant (MATEP), you will be responsible for MATEP’s operational reporting, including internal and external reporting of regulatory compliance and plant financial information, supporting budgets, forecasts, and operating results.
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Familiarity with GMP guidelines and regulatory requirements for mRNbased products. Ensure all processes are compliant with regulatory requirements and industry standards (e.g., GMP, ICH guidelines.
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Act as the primary point of contact for cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and data management. Ensure adherence to clinical trial plans and regulatory guidelines (FDA, EMA, ICH/GCP.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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Contribute to the preparation of regulatory documents and submissions as needed. We are seeking a highly skilled and experienced Senior/Principal Scientist with a proven track record in oncology drug discovery, in vitro and in vivo pharmacological characterization, and development.
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The Principal Systems Analyst will be responsible for analysis of the current and new business and technical processes, identifying system interfaces and dependencies, and documenting process and system flows.
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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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IntelligenceBank is the leading digital asset management and marketing operations platform for brands in regulated markets, including Hyatt, Hertz and KFC. Used by over 800,000+ users in 53 countries, IntelligenceBank uses AI and automation to help ensure brands get to market quickly, stay on brand and ensure regulatory compliance.
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The incumbent will support internal and external deviations/investigations, change controls, and authoring/review/approval of protocols, reports and relevant sections of clinical and commercial regulatory submissions (IND/IMPD, NDA/MAA) as well as the completion of commercial Annual Product Quality Reviews.
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We are a human-centered group that partners with our clients to provide expert HF consulting services, whether it’s delivering an entire usability engineering program alongside device development teams, guiding clients on HF regulatory strategy, providing HF advisory support to our in-house teams, or conducting generative, formative, validation, and comparison studies.
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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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regulatory affairs jobs Title: principal consultant Company: Parexel in Watertown, MA
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