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Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, defining additional nonclinical study plans and test compound requirements, and developing overall project timelines and associated budgets.
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Advise the Vice Provost for International Affairs and other University leaders on emerging andor urgent threats and risks to University interests stemming from geopolitical or other safety and security developments in the United States and abroad.
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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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The Director of Gene Editing Analytics and Strategy will work on a cross-functional team to characterize gene editing in cell therapy products as well as establish and obtain regulatory approval for product release strategies.
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Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS.
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What you will do The Counsel, Regulatory will be responsible for providing analysis and legal counsel on a wide range of legal issues, including regulatory affairs, advertising claims and healthcare compliance, conducting legal research, preparing legal documents, and drafting commercial contracts.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety requirements.
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Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function.
$53 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Dispose of radioactive materials and store radiopharmaceutical, following radiation safety procedures and regulatory guidelines. Dispose of radioactive materials and store radiopharmaceutical, following radiation safety procedures and regulatory guidelines.
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Work with social work director to ensure that the department services and staff remains in compliance with various regulatory bodies such as Joint Commission, Medicare, Medicaid, and the New Jersey DHS, DMHAS and DCF and annual required trainings and licenses.
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Acts as a registered lobbyist on behalf of NJHA before state legislature, the Governor’s office, and various state regulatory bodies as needed. Objective: Analyzes legislative and regulatory issues as they pertain to member interests; assesses political impact of these issues on the industry; attends legislative and regulatory hearings; prepares issue briefings; perform policy research on issues relevant to NJHA; and, produces written reports for members, the public and policymakers.
$90,000 a yearExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Key internal relationships include brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory. Other internal relationships include Public Affairs, Government Affairs & US Corp Giving & Social Impact.
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Key Responsibilities:Environmental Litigation: Represent clients in environmental litigation and enforcement matters, focusing on both state and federal environmental regulations, including CERCLA, RCRA, Clean Air Act, and Clean Water Act. Environmental Compliance: Advise clients on compliance with federal and state environmental regulations, helping them navigate complex statutory and regulatory requirements.
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Must be adept in Metrc regulatory database, Excel spreadsheets, developing and tracking KPI’s, inventory management, labor forecasting, and efficient task delegation. The Cultivation Manager oversees all cultivation processes to ensure department adherence to track & trace requirements, cultivation schedule deadlines, quality control, IPM program execution and materials/inventory requests.
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regulatory affairs jobs Title: pediatric Company: Maxim Healthcare Services in Monmouth Junction, NJ
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