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The Associate Director of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) as appropriate, and participating in label-related Health Authority negotiations.
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Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products And Devices
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The Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation.
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Ensure alignment of labeling strategy with overall regulatory and program strategy by collaborating with internal stakeholders including Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
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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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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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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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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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Targeting 8 years of progressively responsible Regulatory Affairs experience and 6 years’ experience in global labeling. Key Skills: Must have a strong track record of leading labeling content development through regulatory submission and review process, Health Authority negotiations resulting in product approvalDemonstrated experience in developing and executing complex and innovative global labeling strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to labeling negotiations with regulatory authorities.
$185,000 - $230,600 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team and Executive Labeling Committee as appropriate, and participating in label-related Health Authority negotiations.
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4 or More Years of direct regulatory affairs experience, including US labeling experience required. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS.
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Bachelor or Master’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years’ experience in the pharmaceutical industry with 1-2 of those years in regulatory affairs preferred.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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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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Join Takeda as an Associate Director, Global Labeling Lead where you will be responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.
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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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