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Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics – New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium.
$187,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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He/she/they 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/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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US Medical Affairs leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA.
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Collaborate effectively with various project team members such as preclinical/clinical affairs, quality engineering, operations, regulatory affairs, marketing, etc. Self-directed work with project teams to provide characterization strategies aimed at supporting discovery efforts, new product development, regulatory submissions and post launch activities.
$88,000 - $141,450 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance." Must have Bioanalytical experience so they can help lab troubleshoot issues when applicable, Outsourcing experience preferred but the major focus/must haves should be at least 5 years (with masters or higher degree) or 10 years (with bachelors degree) bioanalytical experience, regulated experience, experience supporting clinical studies, biomarker ops or analysis.
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Regulatory Affairs, Compliance and Legal. The incumbent interfaces with Clinical, Medical Affairs and business partners including Marketing, External Affairs and Market Access.
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Any other administrative duties as deemed necessary by the Director of Engineering & Regulatory Affairs. Track pending legislation in the markets specified by the Dir. of Engineering & Regulatory Affairs.
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This position will partner with other members of the Compliance organization and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal.
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The Director will develop collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development, Advocacy, Commercial and Market Access) as well as external medical experts and will have an integral role in driving the planning and execution of scientific communications deliverables across the Insmed respiratory franchise.
$179,000 - $250,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions.
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Knowledge of integration requirements, security protocols, data privacy, and regulatory compliance about enterprise architecture, D365, and Microsoft Power Platform. Collaborate with security and compliance teams to ensure adherence to data privacy, security standards, and regulatory requirements.
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He/she/they 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/they 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.
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Knowledge of assay validation, updates, and regulatory filings in a commercial setting. Address necessary implementation needs including procedure generation, equipment qualification, assay validation updates, and regulatory filings.
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings.
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regulatory affairs jobs Title: director clinical assoc in Bedminster, NJ
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