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Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products.
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Evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead.
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Proven leader with a minimum of 15 years of experience in regulatory affairs and related technical documentation for complex medical devices including software, hardware, and disposable components.
$196,700 - $245,900 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Piper Companies is searching for an Experienced Regulatory Affairs Professional in Advertising & Promotion to lead the neurology regulatory affairs team of a global biopharmaceutical company as Associate Director of Regulatory Affairs (Advertising & Promotion.
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Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
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Work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Packaging and Manufacturing to develop requirements for labeling text. Additionally, partner with Marketing and Regulatory to develop and finalize content and product branding elements of packaging & labeling for both the US and Global markets.
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Job DescriptionRegulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$177,905 - $230,230ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The ideal candidate will collaborate closely with the CMC and Supply Chain team as well as with key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs, and Quality Assurance.
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Develop and implement regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs. Review protocols, reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments.
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As the Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. This group serves as the "center of excellence" supporting all US RA development projects and products across Ferring's portfolio.
$174,000 - $254,150 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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10-12 years of experience in regulatory affairs preferably in a cosmetic or personal care products company; additional experience in quality control is a plus. Must be a practitioner of and have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada.
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Manage and direct staff to regularly audit regulatory files and control documents such as SDS, COA, Spec, and Stability to ensure all information is accurate and up to date in preparation for any formal audits.
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Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market. Head of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects.
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What you'll do:Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
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