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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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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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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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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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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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The Government Affairs Manager plays a key role in crafting and shaping federal and state legislative and regulatory policy issues for the benefit of IEHP. The Government Affairs Manager has an active and visible leadership role with the state and federal advocacy associations and legislative offices.
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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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Have substantial legal experience in environmental law, federal and state regulatory affairs including enforcement, land use, and litigation. This position will provide legal counsel and advice on the City of Atlanta’s (the “City”) environmental matters, including drinking water, wastewater and storm, water treatment and compliance; solid and hazardous waste management; sustainability and environmental nuisances, contamination, and clean-ups.
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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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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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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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The Regulatory Affairs Manager is responsible for managing regulatory activities in the U.S. and being a business partner to other teams. Regulatory Affairs Manager.
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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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The primary purpose of this position is to serve as a Public Affairs Specialist, to carry out a wide range of public affairs assignments that include elements of media operations, social media, community engagement, command information, visual information, communication planning, contingency/crisis response, special event planning, environmental, security, policy review.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Parexel
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