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Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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Advanced knowledge of the international/sustainable development, public policy, and public affairs and international development job markets spanning the public, non-profit and private sector (in the US and internationally.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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Medical Affairs Strategy and Planning: Collaborate with the medical affairs leadership team to develop and execute medical affairs strategies, objectives, and plans aligned with business goals and regulatory requirements in relation to medical communications and publications.
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Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports.
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Serve as the main administrative coordinator for the Office of Student Affairs events and work independently to oversee event logistics (including event planning, social media, event promotion, room set-up/clean-up, catering, AV, and IT) and coordinate with departments and offices on main campus and at the law school as needed.
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Responsibilities: Gather information, format, and assemble regulatory submissions, particularly IND Chemistry Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriatePerform technical editing (i.e., references, internal/external linking, definitions, acronyms, etc.
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? The Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes.
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In collaboration with Quality, Technical Operations, Regulatory Affairs, Clinical Operations, and Finance support automation (Veeva, SAP, logistics), document management (Veeva Vault, Veeva RIMS), and learning management (ComplianceWire) strategies for Kyverna’s operations including qualification, validation, and lifecycle management support.
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NAGPRA Registrar (9722C), Government & Community Affairs - 67034 About Berkeley At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that students, faculty, and staff of all backgrounds feel safe, welcome and included.
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Housing regulatory agreements, fair housing laws, affordable housing management principles, and the affordable housing development process, ability to understand local landlord/tenant regulations.
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The Chief Compliance Officer (“CCO”) will act as the primary expert and advisor on all NerdWallet compliance matters, managing external regulatory engagements, legal contracts, and third-party vendor compliance.
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Plan and execute client engagements focusing Operational Risk, Operational Resilience, Regulatory Compliance, Surveillance, Conduct Risk, Third Party Risk Assessments and other risk programs. Sia Partners is looking for a talented Management Consultant to support our Risk, Regulatory & Compliance Business Unit serving our clients as a project manager.
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Work with the Renewables Americas Permitting and Environmental Affairs teams to coordinate thereview of required permittingand environmental impactsubmissions e.g., EFH and MMPA documentation. Serve as a primary technical expert for a variety of communities, government representatives, non-governmental organizations, and academia on fisheries or water resource management.
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regulatory affairs jobs Title: affairs specialist Company: Amgen in Oakland, CA
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