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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. Required Knowledge: Regulatory, Scientific/Technical, QA, Business acumen.
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Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA.
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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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This position is ideal for self-starters with bank auditor experience, regulatory examiner experience or banking industry experience within risk management. Audit experience within Banking, Accounting / Consulting, Regulatory Agencies, or Financial InstitutionsCertified Internal Auditor (CIA) or willing to obtainAdditional Certifications:CRCM, CPA.
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This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
$225,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Partner across functions to ensure robust systems in place to meet regulatory and stakeholder expectations in the areas of environmental compliance, product compliance, supplier conduct, and sustainability/ESG; support response to internal and external stakeholder information requests in these areas.
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This will include tools and frameworks for budget, timeline, and asset management as well as project administration and business affairs; clearance, trafficking, agreements, compliance, etc. You will lead a team responsible for infrastructure, equipment and talent for live action, post production and visual effects / motion graphics / animation for film, production design, versioning, retouching and print production for static and digital assets.
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This position reports to the General Counsel and handles projects associated with various areas of law, including commercial and consumer lending, transactional work, regulatory issues, Fintech issues, litigation (including third party litigation) management support, and bankruptcy.
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Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Purpose and Scope:The Medical Lead, Oncology, MUS (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA.
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The Senior International Learning Manager collaborates with International Marketing, Areas, and Affiliates and to create learning programs and capability development solutions primarily for new product launches, mature products, promotional or regulatory updates, and new hire training.
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QUALIFICATIONSEducationBachelors Degree (± 16 years)In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields are preferred or an equivalent combination of education and work experienceMasters Degree (± 18 years)PreferredDoctorate Degree (± 19 years) PreferredExperience/BackgroundMinimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field.
$324,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Combination of education and experience where I have successfully completed a community planning degree, or a degree in a related discipline such as urban affairs, architecture, landscape architecture, engineering, sociology, geography, economics, political science, or public administration and have one (1) year of work experience in community planning acquired under the supervision and guidance of a community planner.
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Inform Bank management and lines of business regarding changes to Federal and State regulatory law. Attend applicable regulatory training, seminars and conferences to maintain regulatory consumer compliance knowledge.
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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 offer a competitive total rewards package, including a stable base salary, to recognize associate achievements.
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regulatory affairs jobs Title: sr regulatory associate Company: Modis in Deerfield, IL
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