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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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Large MLTC program with locations around NYC, is currently seeking an experienced Regulatory Affairs Associate to join their dynamic and dedicated team. Regulatory Affairs Associate – MLTC Program - Hybrid.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
$7,500 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function's Executive Office.
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Senior Manager, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will be responsible for working with internal and external constituents to develop and advocate Federal energy regulatory and market policy positions on behalf of Constellation.
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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek
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