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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.
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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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A minimum of 0-3 years of experience in Product Stewardship, SDS Authoring, or Regulatory Affairs. Reporting to the Sr. Manager, Global Regulatory Affairs, the job holder will assist the Product Stewardship team with a variety of administrative and data management activities to support global regulatory activities.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
$130,000 - $150,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA.Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
$118,000 - $147,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The ICM System Regulatory Specialist is the primary point person for maintaining the system case management policies and procedures. Accredited Case Manager (ACM) - American Case Management Association (ACMA); California Registered Nurse (RN) - CA Board of Registered Nursing; Master's Degree; Certified Professional in Healthcare Quality (CPHQ) - National Association for Healthcare Quality; Bachelor's Degree; Certified Case Manager (CCM) - Commission for Case Manager Certification.
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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 therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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Develop and execute global Regulatory strategies across nonclinical, clinical, quality and CMC functions, for gene editing therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance.
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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
regulatory affairs specialist quality jobs Title: engineer
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