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Engage with regulatory agencies and industry stakeholders regarding regulatory and legislative affairs, including by providing feedback on proposed regulations. 2+ years' experience working in regulatory compliance or regulatory affairs for a consumer products, food, beverage, cosmetics or pharmaceutical company, or in a highly regulated industry.
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Assists the Assistant Dean of Student Affairs in determining resource allocation, including budgets and staffing, for student programs, organizations, and events. Essential Duties and Responsibilities: Under the direction of the Assistant Dean for Student Affairs, do the following: A. Guide to Professional Success (GPS) –Scheduling - Oversees and manages GPS CalendarSchedules rooms and appropriate educational technology support for GPS sessions Communication - Manages GPS communication Ensures timely and effective correspondence with session presenters, learning community mentors, and students via email, news board, and student assignments.
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The position will report directly to the Laboratory Director and work alongside technical staff specialized in fields of analytical, toxicology, and regulatory affairs as well as other labs and functions.
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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
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This new position will work closely with Global and Regional Market Access, HEOR, Marketing, Medical & Clinical Affairs, Research & Development, and Government Affairs colleagues to help ensure patients gain appropriate access to Abbott’s life changing point of care, rapid diagnostics.
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Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$56,000 - $60,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Provide overall oversight of school to ensure adherence with the Federal Head Start Program Performance Standards, ISBE Preschool for All/Prevention Initiative requirements, DCFS licensing guidelines, organization policies and procedures, and mandates from all funders and regulatory agencies.
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What you'll be doingThe Medical Science Liaison (MSL) functions as a field-based member of the Medical Affairs group in Medication Delivery, Baxter Healthcare Corporation. This role will collaborate with the internal Commercial and Medical Affairs teams in their therapeutic area of expertise to provide scientific information relevant to the launch of new products, and support key product strategies and publications.
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As a safety representative, the Scientific Director will be responsible for the overall strategy and execution of the nonclinical toxicology program, collaborating cross-functionally with project leads, providing data interpretation at various internal and external venues, and authoring regulatory documents.
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Bachelor’s degree and at least 4 years of experience in Regulatory Affairs and/or Compliance OR a High School diploma/GED and at least 7 years of experience in Regulatory Affairs and/or Compliance.
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Cell Therapy functions (CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.) Broad technical expertise with biologics or cell therapy commercial manufacturing & analytical processes, technology transfer and/or start-up phase experience highly desired.
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Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
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Prepare reports for use by company personnel and regulatory agencies including all required EHS reports for EPCRA, SARA, Title V, NPDES, etc. Job Description Provide EHS project management support on EHS matters including negotiating strategies, technical problem solving, responses to written correspondence & inquiries, compliance inspections and regulatory interpretations.
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Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory.
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You will report to the Director, Corporate Affairs Operations and will support teams within Corporate Affairs that includes Legal, Ethics and Compliance, Security Loss & Prevention and Environmental Health & Safety.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma in Mettawa, IL
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