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Regulatory Affairs representative for theCT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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You will work closely with cross-functional teams, including regulatory affairs, labeling, quality control, and product development, to ensure that our products meet all applicable food safety and compliance requirements, and will support management of any administrative proceedings or litigation related to TreeHouse Foods' adherence to safety regulations, compliance standards and best practices.
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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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Knowledge of global regulations is necessary to provide regulatory affairs support to ongoing global clinical trials and to review global submissions to these trials. 8-10 years of relevant pharmaceutical/biotechnology industry experience including 6+ years of experience in Regulatory Affairs related development of pharmaceuticals; phase 1 through NDA and post-approval.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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The Senior Regulatory Affairs Specialist supports product development as a core team member and is responsible for regulatory submissions and registrations. Job Title: Senior Regulatory Affairs Specialist.
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Provide legal guidance and support on a wide range of regulatory and medical affairs matters, including but not limited to pre-market approvals, submissions and responses to the FDA, quality systems, commercialization, advertising, promotions, marketing, communications and labeling for on-label and off label products, new product introductions and revenue models, post-surveillance, inspections, deficiency/warning letters and/or recalls.
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Job Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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The Senior Director, Regulatory Affairs CMC is responsible to manage and help develop regulatory strategies to support development of innovative products, as well as to ensure efficient management of approved and marketed products.
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Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded.
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As part of the Regulatory Affairs team, the RA Associate will be responsible for ensuring faultless compliance of product labeling for several brands within Albertsons Own Brands.
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At minimum of ten years’ experience managing teams in International Regulatory Affairs and advising manufacturers on a broad range of product regulatory affairs, and securing regulatoryapprovals from bodies such as the FDA, USDA and EFSA (European Food Safety Authority);prior experience advising industrial minerals manufacturers is very desirable.
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Lead and develop a team of regulatory affairs professionals in areas such as HazCom management, product stewardship, new product development support, labeling reviews, and lifecycle support activities.
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Supported teams include clinical trials, clinical evidence, quality, Research and Development (R&D), regulatory affairs, post-market surveillance, marketing, business development, and other functional units.
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