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As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms. At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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The Manager/Associate Director, Health Economics and Outcomes Research (HEOR) Hepatology/Virology will join a high caliber team to execute HEOR strategies and tactics for Hepatitis C and early pipeline assets in virology.
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We are looking for an experienced Regulatory Affairs Manager to manage the entire Product Registration, including being the primary contact with all certification entities, regulatory agencies (including customs), and independent laboratories, including, but not limited to, WQA, NSF, IAPMO, and UL for Culligan Consumer Products Division.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Title: Senior Manager, CMC Regulatory Affairs. 8+ years industry experience; pharma, CRO or academic with at least 3 years’ experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories.
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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California.
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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision , prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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The IT Sr Manager, Technical Product Manager for Regulatory Excellence combines modern Information Technology (IT) expertise, and knowledge of the pharmaceutical development business to transform the way IT is applied in Regulatory Affairs with a focus on systems unifying the processes related to Regulatory Operations and the overall user experience of our business customers.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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Keys: Medical devices, medical device reporting (MDR/eMDR), FDA and European/notified body inspector interface, Regulatory Affairs, CAPA, complaint/adverse event regulatory, post market surveillance and external audits, and reporting.
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The Group Leader Regulatory Affairs – Regulatory Affairs Manager will manage a TEAM (remotely) of three RA professionals. The Group Leader Regulatory Affairs – Regulatory Affairs Manager will be expected to work on all aspects from strategy through to implementation and have the broad skills and knowledge to ensure successful outcomes.
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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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Country: United States City: Chicago Job Family: Quality Regulations Expertise Contract Type: Unlimited-term Job ID: 50311 Regulatory Affairs Manager Bel, makers of iconic cheese brands including Babybel, The Laughing Cow, and Boursin, is a growing global company that values your contributions, strives to create a sense of belonging for everyone and offers career growth and development opportunities, as well as competitive total compensation and meaningful well-being benefits from day one.
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