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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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Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and risks that may impact regulatory success.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Act as a liaison between cross-functional teams, including clinical operations, regulatory affairs, finance, and business development, fostering strong communication and collaboration throughout the contract lifecycle.
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Bachelors degree in a science field with at least nine to twelve years of Regulatory Affairs experience in a biotech and/or pharmaceutical setting. Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple biotechnology and pharmaceutical sponsor engagements.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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The College's schools, departments, and programs—with disciplines ranging from economics and history to English, urban affairs and international affairs, form an interdisciplinary group of scholars with global perspectives and a culture of inclusion.
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The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Market Access, Medical, Research and Legal.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Knowledge of current regulatory guidance and experience in managing IND/IMPD filing.
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Reporting Structure: The Graduate Housing Director will report to the Associate Director of Auxiliary Services within the Campus Planning and Facilities department while closely collaborating with Student Affairs, Residence Life Management, and other relevant departments.
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Massport's Capital Programs & Environmental Affairs Department is dedicated to advancing the vision of transforming our industry through groundbreaking approaches, consistently delivering "best-in-class" infrastructure projects that create exceptional value and surpass the expectations of our valued clients and customers.
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Director, Model Validation for SHUSA Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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In collaboration with the Associate Chief Nurse, the Nursing Director plans, organizes, implements and oversees clinical and program development in the assigned area(s) to contribute to meeting the mission and goals of Brigham & Women’s Faulkner Hospital as well as the regulatory requirements of the JCAHO and other applicable federal, state and local regulatory or accrediting agencies.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Dorchester Center, MA
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