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The Regulatory Training Specialist works with other training specialists in MRTS and Regulatory Operations to assist in the development, design and delivery of learning solutions that support FINRA's mission of protecting investors and safeguarding market integrity in a manner that facilitates vibrant capital markets.
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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
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Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and Safety Sciences (CPSS) function; we’re looking to recruit a talented and experienced reproductive toxicologist to join our reproductive toxicology team.
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Provide thought leadership and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons, and medical communication while working closely with the clinical development and regulatory teams.
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In the preparation and review of bioanalytical data and reports suitable for regulatory submission. in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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15 years of experience in drinking water treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, distribution water quality analysis, etc.
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You will maintain expertise in regulatory requirements and preclinical safety approaches applied to Immuno-Oncology therapeutics and awareness of industry trends. You will contribute to early oncology project decision making, address specific concerns, and present findings to ensure that teams can make the right decisions regarding safety risks that facilitate timelines and regulatory submissions.
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The Technical Expert is responsible for understanding the regulatory and policy landscape for genetic biocontrol approaches to control malaria and other vector-borne diseases; planning and implementing a portfolio of activities to provide technical information and advice on regulation and policy to stakeholders; and collaborating with partners to build regulatory and policy capacity, particularly through online and in-person trainings.
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Ability to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory Affairs. Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
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Background in pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements is required. Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements.
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Provide clinical documentation using malaria databases, NIH electronic medical records, and regulatory documentation of events post-vaccination. Must have experience with WHO and FDA regulatory authorities as it pertains to the conduction of human clinical trials.
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Regulatory expertise, specifically GCLP and GLP, to support clinical trials and preclinical regulatory studies. The Clinical Project Leader (CPL) serves as the primary point of contact for Champions vast portfolio of client sponsors regarding Champions aspects of sponsors clinical trial execution, regulatory requirements, data transfer, and general project management.
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Do you have previous experience in animal care and/or control (e.g., animal services officer, veterinarian assistant, attendant at an approved kennel) or regulatory compliance and enforcement, law enforcement, military, or related field.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Responsibilities include coordinating and analyzing samples using immunoassays (ELISA, Luminex, Meso Scale, etc) and cell assays (flow cytometry), maintenance of biobanks and inventories, developing assays, and reporting to cross-functional teams.
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Examples may include use of regulatory guides, industry codes, and standards, Federal and state emergency preparedness and incident response programs, and applicable FEMA or EPA regulations/guidance.
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regulatory job Title: regulatory affairs assistant Company: Jobget in Gaithersburg, MD
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