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The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF.
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The Engine Division of Kawasaki Motors Corp, headquartered in Grand Rapids, MI has an immediate opening for a Regulatory Compliance Manager based in Grand Rapids, MI. As a Regulatory Compliance Manager, you are responsible to lead Kawasaki's regulatory compliance activities ensuring that Kawasaki and its product's comply with all requirements while identifying new technologies and future improvements.
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The Senior Manager/Manager Regulatory Document Submissions will report to the Director of Medical Writing, Regulatory. Senior Manager/Manager Regulatory Document Submissions.
$126,500 - $160,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As the Program Manager, Regulatory Compliance you will drive continuous improvement initiatives to enhance our compliance posture coordinating internal individuals responsible for the in-scope business process or product.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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Significant track record in leading regulatory operations staff through major global submissions (NDA, MAA etc) Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function; ensure that Company's practices are in conformance with the latest health authority and industry submission standards.
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Researches energy policy and evaluates business impacts to ensure the company remains competitive under evolving federal and state regulatory environments. Experience with regulatory agencies including FERC and PUCs in AZ, CO, TX, NM. Criteria/Conditions: Position requires travel up to 25% of the time.
$118,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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8+ years of professional experience as either a healthcare litigation, regulatory, or transactional associate in a nationally recognized law firm, in-house counsel at a nationally recognized company or organization, or a combination thereof.
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As the Program Manager, Regulatory Compliance you will drive continuous improvement initiatives to enhance our compliance posture coordinating internal individuals responsible for the in-scope business process or product, establishing a common framework across the enterprise to ensure regulatory compliance awareness and inform the business' risk assessment as it pertains to regulatory compliance and conduct.
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The right candidate will have a basic understanding of and enthusiastic belief in the cryptocurrency/digital asset space, 12+ years of relevant litigation and regulatory experience at a top law firm or in-house at a fast-paced, brand-name business, and possess strong academic credentials and excellent writing and analytical skills.
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Experience in Business or System Administrator is a plusExperience with managing vendors/consultants/partners (e.g. external publishing vendor)Strong understanding of Regulatory Operation comprehensive roleDesirablePrior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferredExperience with BLAs/NDAs/MAAs preferredExpertise in Veeva RIM, system implementation experience a plus.
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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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The Safety Manager - Regulatory Compliance will lead a cross functional team that handles critical regulatory compliance programs throughout AmeriGas. The compliance responsibilities include Process Safety Management (PSM), Risk Management Program (RMP), Office of Pipeline Safety (OPS), and Department of Homeland Security (DHS) related activities.
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Develop a regulatory management program to ensure consistent implementation of PSM, RMP, OPS, DOT and DHS initiatives across AmeriGas and to monitor compliance. Communicate regulatory updates and risks associated with applicable agency regulations to AmeriGas Leadership Team.
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Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization’s biologics product franchises in accordance with domestic and international regulations and guidance.
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Title: regulatory manager Company: International Trucks
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