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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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10+ 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.
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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.
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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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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Company's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Candidate must have knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
$71,572.8 - $93,038.4 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Tessenderlo Kerley, Inc. is adding an additional Regulatory Affairs Manager to join their talented Regulatory team. As a Regulatory Affairs Manager, you will interact with internal and external customers, including state/provincial and federal regulatory authorities, in support of NovaSource products.
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Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Senior Regulatory Affairs SpecialistWHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers.
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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 Today - UpvoteDownvoteShare Job
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Compensation for the Regulatory Affairs Specialist, Cell & Gene Therapy. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy. Qualifications of the Regulatory Affairs Specialist, Cell & Gene Therapy.
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Senior Director of Regulatory Affairs and Strategy will develop and implement comprehensive regulatory strategies and oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
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The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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Minimum 8-10 years of combined regulatory affairs experience in color cosmetics, both in domestic and international markets. Strong knowledge and expertise in international regulatory affairs and packaging/labeling compliance.
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Title: regulatory affairs Company: Solar Energy Industries Association
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