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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.
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Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
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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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Expert knowledge of global/regional/local regulatory legislation, laws, procedures, and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals.
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Review product labeling, promotional materials, and advertising materials to ensure regulatory compliance. Program Overview: Lexington’s Summer Intern Program is intended to attract undergraduate and graduate college students who are studying Biomedical Engineering, Regulatory Affairs, or other related fields.
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Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company with locations in Georgia, North Carolina and Massachusetts. You will manage the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the assigned product Regulatory Leads, Regulatory Labeling as well as Advertising and Promotion Scientist Leads.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Ability to understand regulatory implications of product strategy related to labeling development, assessment and management. Serves as primary contact for Labeling Strategy Team (LST), eg Global Regulatory Lead (GRL), Safety Management Team Lead (SMTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally.
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Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Lead preparation of the regulatory strategy document and target product labeling.
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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.
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Collaborates with other functional work teams e.g., Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials.
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The call to action to extend and improve the lives of cancer patients is louder than ever before, and Syndax is seeking individuals who are committed to science, innovation, and excellence to join us on this mission.
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How you will contribute: 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.
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Proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products. Typically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 3 years of supervisory/management experience, or the equivalent combination of education and experience.
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This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
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Evaluate regulatory risks and make recommendations relative to the labeling strategy. Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components.
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labeling regulatory jobs in Waltham, MA
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