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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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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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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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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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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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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 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 PDM, Regulatory Affairs, and Clinical Development.
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The Director, Transmission Policy Advocacy be based out of Invenergy’s Washington, D.C. office and report to the SVP, Transmission Public Affairs while collaborating closely with Invenergy’s federal affairs, regulatory, permitting, and transmission business functions.
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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. Responsibilities Prepare regulatory documentation for flavors and essential oil products - SDS, Allergen statement, Natural status, GMO, Prop 65, flavor product Ingredient listing, etc.
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Assist the Regulatory Affairs Manager with compliance-related inquiries and certifications as needed. The Regulatory Affairs (RA) Analyst is responsible for ensuring compliance of raw material documentation, finished product documentation, and finished product packaging with internal specifications and external regulatory requirements.
$90,000 - $105,000Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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Minimum of 5 years of experience in regulatory affairs, specifically within the dietary supplements or related industries in the U.S. market. As our Regulatory Affairs Manager, you will play a crucial role in our product development team by ensuring that all new and existing products comply with regulatory standards in the United.
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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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regulatory affairs jobs Title: principal Company: Parexel
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