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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 6 days ago - UpvoteDownvoteShare Job
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
RemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Medical and Scientific Affairs serves a critical internal leadership and customer-facing support role, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Strategy, Pharmaceutical Partnerships (Companion Diagnostics), and Technical Support.
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This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Leads deal team for transactions typically ranging from approximately 1MW to 1000MW with 3 to 36 month terms that yield revenues up to $700MM; team includes traders from power, transmission, mid-marketing, green, and options desks as well as representatives from valuation, legal, credit, risk, accounting, and regulatory/legislative affairs.
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This individual will build strong cross-functional relationships with Gilead’s Value and Access, Medical Affairs, Regulatory, Legal, and Public Affairs teams. Partner as appropriate with US Federal Government Affairs to align Gilead’s outreach with key US Government Agencies, such as the State Department, the Department of Health and Human Services Office of Global Affairs, the US Department of Commerce, USTR and relevant departments to support regional objectives.
$232,220 - $300,520ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapySelf-organizer, meticulous hands-on habits, keen attention to detail.
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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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To foster a positive, creative, psychologically safe work environment within the US Pharmaceuticals team and the broader Global Regulatory Affairs organization. In collaboration with Regulatory Policy and Intelligence group, lead team to participate in industry associations to influence adoption of best practices in animal health regulatory advocacy programs critical to Elanco business success.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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As a key member of our legal department, the Senior Manager of Regulatory Affairs/In-House Counsel will play a crucial role in managing regulatory compliance, with a primary focus on collections and litigation.
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regulatory affairs jobs Title: intern Company: Amgen
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