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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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Responsibilities The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. The Regulatory Affairs Associate will serve as a liaison for PI(s)/study team and various internal/external regulatory oversight groups.
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Maintains awareness of regulatory legislation and assesses its impact on business and product development programs. The Manager/Associate Director, Health Economics and Outcomes Research (HEOR) Hepatology/Virology will join a high caliber team to execute HEOR strategies and tactics for Hepatitis C and early pipeline assets in virology.
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In addition, this position will have knowledge of and represent these research programs in all regulatory affairs requirements mandated by the three Cancer Consortium partner institutions: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington, in addition to the governmental regulatory requirements.
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BryceTech is looking for an experienced Regulatory Affairs Analyst to support the DHS FEMA, Office of Response and Recovery, CBRN program, supporting the Office of Emerging Threats Professional and Technical Services Contract.
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The Director/Sr. Director, CMC Regulatory Affairs is responsible for development and lead of the CMC regulatory strategy for early-stage T-cell therapies. Director/Sr. Director, CMC Regulatory Affairs.
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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.
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Job Title Sr. Regulatory Specialist-CT/AMI Job Description The 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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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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Highly reputable, established, Fintech looking to appoint a Legal Counsel/ Financial Services Regulatory Counsel in NYC to expand their In-House legal and regulatory compliance capability/ team.
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Analytics Insights, Business, Business Direction, Client Relationship Management, Finance, Global Market, Marketing Strategies, Portfolio Management, Regulatory Compliance, Sales, Structured Products.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply 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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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
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regulatory job Title: sr regulatory affairs associate Company: Kelly Services
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