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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$218,500 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The PGDx Regulatory Affairs and Quality Assurance Teams ensures the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
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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.
$347,380 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Legislative/Regulatory:Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
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This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
$284,375 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Thermo Fisher Scientific
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