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This position is part of the Medical and Scientific Affairs and will be fully remote. Provide pathology expertise and medical insight for the development of assay design specifications; design and execution of IVD and CDx studies; creation of training materials and interpretation guides; contribution to regulatory strategy and submissions; participation in meetings with regulators (e.g. FDA); review of marketing and promotional materials.
$250,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement.
$231,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our client, a specialized and stable pharmaceutical facility in the mid west, is looking for a Director of R&D (Scientific Affairs) to lead the scientific and technical aspects of API development and manufacturing within the company.
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This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.
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Strong business acumen, analytical skills, and experience working with various internal business partners (especially Sales, Marketing, Clinical, Regulatory, Legal, and Government Affairs staff) to provide insight into key economic and reimbursement issues for transcatheter heart valve products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The role will close collaboration with the Medical Directors and the Chief Medical Officer and with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Ensure that CMC quality systems, validation, product specifications, product release, reference standard and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
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Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies. Support the coordination and management of regulatory agency inspections, and inspection readiness efforts which may include mock internal inspections and vendor audits.
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Compliance and Regulatory Affairs: Ensure compliance with all applicable laws, regulations, and licensing requirements related to IDD services. Innova Solutions is currently seeking a DIRECTOR OF BUSINESS OPERATIONS to be responsible for overseeing and managing our client's business operations, ensuring efficiency, effectiveness, and compliance with regulatory requirements for their IDD (Intellectual and Developmental Disabilities) population.
$125,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Associate Director Regulatory Affairs is an integral part of our Regulatory Affairs team based out of our US - Teaneck, NJ site. Bachelor’s degree, preferably in a scientific field or animal health with 8+ years of work experience in regulatory affairs.
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Collaborate with other organizational departments responsible for functional aspects of the HIV Special Needs Plan, including, but not limited to Integrated Care Management, Behavioral Health, Managed Long-Term Care, Utilization Management, Quality Management, Credentialing, Regulatory Affairs, Compliance, Corporate Affairs, Provider Network Operations, Medicare Services, Information Systems, Finance, Claims, and Member Services and Eligibility.
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In collaboration with Regulatory Affairs, responsible for departmental compliance with New York State Department of Health regulations, The Joint Commission (TJC) Performance Improvement and National Patient Safety Goals chapters, CMS Conditions of Participation, NY and NJ Departments of Health codes rules and regulations and other regulatory/external agency requirements (e.g., FACT) by ongoing monitoring and evaluation, establishing work plans as required and prioritizing their implementation.
$329,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We have partnered with an innovative medical device company in Illinois seeking a Director Quality and Regulatory to join their dynamic team. Independently review risk management studies, manage document control, and ensure compliance with regulatory standards.
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Outside of the Platform, the colleague will work with assigned franchise & asset leaders from R&D, Portfolio Management, CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, Market Access, Business Assessment & Development, Digital, Legal/Compliance, and others to achieve research and business objectives.
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They are looking to bring on a Senior Director, Regulatory Affairs to the team. Experience in leading regulatory affairs across multiple major geographic areas and handling both small molecules and biologics.
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regulatory affairs jobs Title: director in Bronx, NY
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