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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. 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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Under the direction of the Director, Federal Regulatory Affairs, you would be responsible for monitoring, analyzing, and drafting responses to a prescribed set of federal regulatory and reimbursement-related issues and representing the American Heart Association before federal agencies.
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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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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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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#Protocol Review and Regulatory Affairs department is looking for a Regulatory Startup Project Coordinator Summary: The Regulatory Startup Project Coordinator is responsible for shepherding clinical research projects through the study start up process to ensure activation time-lines meet (or exceed) institutional standards.
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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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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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Consistently adheres to regulatory and compliance policies and standards linked to the job as listed and complete required compliance trainings. An AML Investigations Manager assists the Bank Secrecy/OFAC Officer and the Director, Financial Investigations Unit with maintaining certain aspects of the Bank's BSA/AML compliance program and assists in meeting and maintaining BSA/AML compliance requirements of the Bank. Complies with all applicable, federal and state laws, regulations and guidance, including those related to Anti-Money Laundering (i.e. Bank Secrecy Act, USA PATRIOT Act, etc.
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Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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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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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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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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Director, CMC Regulatory Affairs – BiologicsKEY RESPONSIBILITIESThe Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.
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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: sr director Company: Astellas
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