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Responsible for the global regulatory evaluation of CMC change controls with supervision. Participate in global regulatory interactions with health authorities, with supervision. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
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Our spectrum of Global Information Reporting services range from FATCA, CRS, chapter 3 and 61 tax compliance globally, tax form validation services, Qualified Intermediary and Withholding Partnerships regimes, technology development in these areas, consulting services, controversy, risk management and audit readiness for these regimes.
$84,980 - $193,440 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Dexcom Global Events team is afforded the opportunity to showcase the best parts of Dexcom to the world. Global Corporate Communications is a new group comprised of Public Relations, Enterprise/Internal/Employee Communications and Events.
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Maersk is a global leader in integrated logistics and has been an industry pioneer for over a century. Global Reach, Local Impact: Thrive in a role with international scope, contributing to projects that shape global trade.
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Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.
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Our BusinessWe are a global leader in environmental consulting - made stronger with the recent acquisition of Wood’s Environment & Infrastructure business and Golder - with world-class expertise in environmental, social and governance (ESG), climate resiliency & sustainability (CRS), and earth sciences.
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We are delivering on our commitments as we build an innovative company dedicated to advancing global health. LI-hybrid This position may be available in the following location(s): US - Bridgewater, NJ Bausch Health Companies Inc. is an Equal Opportunity Employer.
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Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale.
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Claims QA – Liaise with the Global Claims QA Lead to ensure alignment of TPA audit plans on an annual basis and support the facilitation of each audit. Quarterly Relationship with our ‘strategic’ TPAs along with the Global Claims Vendor Lead. Claims QA - Liaise with Global Claims QA Lead to agree annual audit regime for TPAs. Risk/ Compliance – As it relates to Sanctions, Financial crime and Conduct risk.
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To succeed as global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible.
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Innova Solutions is immediately hiring a Trial Supplies ManagerJob Title: Trial Supplies ManagerPosition type: Full-time ContractDuration: 06 MonthsLocation: Remote, USAPay range: $74 -$ 78 Per HourAs a Trial Supplies Manager, you will:This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
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Hybrid – Can sit in either Rochester, NY or Bridgewater NJ Other possible sites: Tampa, Florida, St Louis, MO, and Greenville, SC onsite 3 days/week and remote 2 days/week The Global Labeling Lead is responsible for leading labeling artwork development/ revisions projects for medical device products, and assessing changes in standards, regulations, and requirements to identify impact to product labels.
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Comfortable and willing to work within a global organization across functions, channels, and multiple time zones upon request. Establish and manage relationships with key partners and stakeholders across the firm, including the broader FMS business strategy team, FMS investment team, local and global marketing, client service, distribution, compliance, and corporate communications.
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