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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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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.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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The American Heart Association has a phenomenal opportunity for a Regulatory Affairs Manager with our Federal Advocacy Team in our Washington, DC office (home-based work arrangements available.
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The Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle.
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Collaborate closely with colleagues in Legal, Administration IT, HR, Finance, Shared Services, Sales and Marketing, Compliance and Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Principal Regulatory Affairs Specialist. 7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience. Propose solutions for Regulatory Affairs questions/issues to RA management.
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.
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This position is PHMSA's Supervisory Attorney-Advisor for Regulatory Affairs Law/Office of Chief Counsel, with comprehensive responsibility for the direct supervision of staff as the Deputy Assistant Chief Counsel for Regulatory Affairs.
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A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelor's degree requires at least 12 years) Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs.
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Our client is seeking a Regulatory Affairs Manager for the Murtha Cancer Center Research Program (MCCRP), Uniformed Services University of the Health Sciences (USUHS) and John P. Murtha Cancer Center (MCC) at the Walter Reed National Military Medical Center in Bethesda, Maryland.
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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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Monitor changes in relevant regulatory areas and provide education on those changes to business and operational personnel and compliance and legal affairs teams. We employ more than 28,000 people who work in inpatient and outpatient clinical care, research, and graduate medical education as well as critical supporting roles in administration, information technology and informatics, finance, legal and community affairs, communications and marketing, fund-raising, groundskeeping and facilities, and many more.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Aerotek
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