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The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC strategies for internal and partner programs. Lead development and execution of regulatory Chemistry, Manufacturing, and Controls (CMC) biomanufacturing strategies for internal and partner programs of all development phases, including varied programs in gene and cell therapy (CGT), antibody bioprocessing (mAb/biAb), mRNA products, and complex biologics.
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The GLMAG is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business.
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The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.
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Technical/Functional Skills Experience Required Critical National Infrastructure (CNI) department currently provides IT support services for Energy Management Systems (EMS), Outage Management Systems (OMS), and Gas Management System (Client) applications that drive the companys operations
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Managing a team of medical safety experts to monitor the performance off all BSC Endoscopy products worldwide, both through commercial activities and clinical trials
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May direct and coordinate activities of less senior Regulatory Affairs staff, including coaching, mentoring, advising and providing feedback. Performs full-range of regulatory functions required for Global product registrations, new product development, and internal documentation review for assigned strategic business units serving as the Regulatory Affairs resource.
$132,000 - $165,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. Must have experience with Class II programmable electro-mechanical and sterile medical devices.
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