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Job DescriptionJob DescriptionSUMMARY OF POSITIONThe Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Clients s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment.
$80,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in CMC regulatory affairs for US FDA, NMPA and EMA is a plus. Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
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Exposure and experience with Governance Risk and Compliance principles and processes, including foundational data models (entity structure), risk frameworks, regulatory/industry frameworks, control frameworks, controls assessments, policies and procedures, cyber security/information technology risk management processes, third party risk management processes, controls management processes, issues and exception management.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Examples are data warehousing, business intelligence (BI), data governance, data architecture, data integration, data classification, data strategy, data quality management, data security and privacy, MDM, real-time data pipelines, data standards, regulatory compliance and enterprise architecture frameworks.
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Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Senior Business Analyst (Robotic Process Automation) (UiPath or Automation Anywhere)Description & RequirementsMaximus continues to grow our Digital Solutions organization to better serve the needs of our organization and our customers in the government, health, and human services space.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The Position The Rapid Cycle Analytics (RCA) Lead Data Scientist role sits within the Clinical Data Science and Evidence (CDSE) team, which is part of CMR. This role interfaces with internal stakeholders from Health Economics and Outcomes Research (HEOR), Real-World Evidence (RWE), Medical Affairs, Clinical Trials Operations, Market Access, and a few other teams to respond to quick turnaround data analytics requests.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$113,325 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The Sr. Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.
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Conduct/assist environmental studies (both field and desktop) and permitting with the New Jersey Department of Environmental Protection (NJDEP), US Army Corps of Engineers (USACE)-Regulatory Branch (Section 404/10), and other federal and state regulatory agencies.
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Familiarity with EMA and FDA regulatory requirements for process development submissions. This position involves close collaboration within MST, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups.
$157,100 - $217,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Seamless cooperation and collaboration with the Global Patent Attorney and global product development team for each product, ensuring that each product developed for the US market has a robust US IP litigation strategy at, or shortly after, the product is put on stability trials, and that the regulatory submission is optimized for US litigation.
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O Uses understanding of Regulatory and Safety requirements to communicate Biomed compliance to departmental owners. Job DescriptionJob DescriptionWorking under limited supervision, the Biomedical Equipment Technician (BMET) is responsible for assisting in the maintenance of biomedical and related equipment that supports Clinical Engineering operations.
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The Scientific Affairs Manager will also liaise with cross-functional team members including clinical, regulatory, quality, legal, supply chain and will be responsible for managing individual study budgets/milestone payments.
$109,300 - $218,700 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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General knowledge and experience in Federal and NJ land-use regulatory programs including Freshwater Wetlands, Waterfront Development, Coastal Wetlands, CAFRA and FHA. Employee will support interdisciplinary project teams with required field work and preparation of permit applications and supporting materials for obtaining permits.
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Provide Medical Affairs support and input into launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late-stage Oncology pipeline products.
ExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Lawrence, NJ
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