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Clinical Excellence: Oversee the development of digital solutions for clinical trials, patient monitoring, and healthcare analytics, ensuring adherence to regulatory standards and best practices.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs.
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The Regulatory Affairs Manager is responsible for regulatory project responsibility for products across needs-states across the Skin Health & Beauty Segment, which may include oversight to key brands such as (NEUTROGENA, AVEENO); covering a wide range of Regulatory classifications (OTC NDA drugs, OTC Monograph drugs, Cosmetics, Medical Devices, and Dietary Supplements.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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For base business hybrid responsibility, key constellation includes local brands teams (including science hub), respective category brand team, respective category claims lead and regional scientific affairs and activation teams.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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This position reports to the VP, Global Regulatory Affairs. Regulatory Affairs - Bridgewater, NJ - Full Time Summary. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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At least 5 years of experience in a Solution Architect role serving the Regulatory Information Management domain. 7+ years of experience supporting pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM.
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Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Regulatory Affairs Program Lead to support our Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio.
$105,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase.
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Establish and maintain effective team partnerships within HEVA and with key partners such as Value and Access and Medical Affairs+ Establish a strategy for publications support from the HUB and with expert vendor support and ensure performance and quality.
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Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years' experience in Regulatory Affairs; or. Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years' experience in Regulatory Affairs.
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Job Description: Regulatory Operations/Affairs Manager. The External Manufacturing Quality Organization is seeking to recruit a Manager, Regulatory Affairs who will report directly to the Associate Director, Regulatory Affairs and will be responsible for all regulatory support activities within External Manufacturing.
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Title: regulatory affairs Company: Sanofi in Somerset, NJ
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