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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Support regulatory inquiries from the CFPB, FDIC, other federal regulatory authorities and bank partners. Experience handling regulatory matters and have prior relationships with relevant regulators at the CFPB, FDIC, OCC, and other relevant state and federal agencies.
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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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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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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.
$130,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Candidates for Director, Strategy should be passionate about providing quality opinion research to drive client decision making in public policy, social marketing, candidate and ballot issue campaigns, non-profit advocacy, corporate public affairs, and government.
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Ability to communicate and collaborate with other functional areas including drug discovery, nonclinical toxicology, CMC, clinical development, quality assurance and regulatory affairs. Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biotherapeutics; experience having direct interaction with FDA and other regulatory agencies, including submission of IND, NDA and other regulatory documents is required.
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Members of the Academic Affairs Manager (AAM) Team are the direct point of contact between the company and Colleges of Veterinary Medicine (CVMs) and Veterinary Technician Schools (VTS). The Academic Affairs Manager role is a field-based role within Hill's US Professional and Veterinary Affairs (PVA) Team, a team that serves as Hill's direct connection to the veterinary profession and the broader animal health industry.
$88,800 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Experience with clinical trials regulatory affairs, or related clinical trials experience such as clinical research coordinator experience. Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
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Ability to create procedures to interpret and align with regulatory policies, while enabling investigators perform appropriate level of due diligence. Certified Global Sanctions Specialist certification is a plus.
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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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Degree: community planning; or related field such as urban affairs, architecture, landscape architecture, engineering, sociology, geography, economics, political science, or public administration that included at least 12 semester hours in the planning process, socioeconomic and physical elements of planning, urban and regional economic analysis, and development finance.
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Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
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Lead statistical programming activities for regulatory submissions following CDISC standards. Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
$189,000 - $201,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop and implement forms, reports, manuals, policies, procedures, and systems to monitor affordable housing compliance and ensure site staff and supervisors are in compliance with applicable regulatory and funding programs relating to property management compliance.
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regulatory affairs jobs Title: affairs specialist in Oakland, CA
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