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Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP) for PDT BU products.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Regulatory Specialist is responsible for ensuring and maintaining the high quality and accuracy of Private Brands labels through regulatory and legal compliance with current U.S. packaging labeling regulations, brand consistency and clarity of label content.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Accountable for oversight for Takeda’s Plasma-Derived Therapies Business Unit’s Global Labeling function and the formulation of regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Director of US Regulatory Operations (RegOps) is responsible for formulating and implementing operational management creating a best- in -class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen’s Advertising/Promotion and Labeling submissions along with associated tools.
$259,600 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements.
Full-timeRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.
$234,300 a yearFull-timeRemoteExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Perform various in vivo procedures in rodents (primarily mice), such as dosing (IV, IP, SQ, PO), body weight measurements, clinical/in-life observations, sample/tissue harvests, necropsy, blood collection (cardiac, tail vein, saphenous), and euthanasia, while adhering to all standard operating procedures (SOPs), policies, animal welfare regulations, and regulatory procedures.
$103,900 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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As one of the world’s leading law firms, we serve a broad range of clients with market-leading practices in private equity, M&A and other complex corporate transactions; investment fund formation and alternative asset management; restructurings; high-stakes commercial and intellectual property litigation; and government, regulatory and internal investigations.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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When delegated by the TA VP, provides regulatory leadership at the Therapeutic Area Strategy Committee (TASC) to deliver TA strategies, disease state insights, vision and direction to differentiate assets regulatory strategic program risks, regulatory intelligence, and recommendations on portfolio optimization.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for FDA specific aspects of given project topline and in depth on clinical/labeling, CMC/NC, advertising and promotion and/or procedural aspects.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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At least 10 years’ experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review. Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This role includes the management and oversight of the planning, forecasting, packaging, labeling, distribution and return of clinical supplies for assigned clinical trials and collaborates closely with the broader CMC and Supply Chain Management team, as well as with key internal stakeholders such as Clinical Operations, Regulatory Affairs and Quality Assurance.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/biotech environment. Manages and designs key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Familiarity with global regulatory requirements for consumer electronics across wireless, EMC/EMI, safety, environmental, packaging, labeling, and shipping. You will manage projects related to wireless, EMC/EMI, safety, labeling, and environmental regulatory compliance in domestic and international markets.
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labeling regulatory jobs in Boston, MA
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