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Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
$295,290 - $382,140 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Sr Director, CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs.
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Reporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio.
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Initiate and contribute to local and/or global process improvements, which have a significant impact for the CMC Regulatory Affairs Department, and the Pharmaceutical Development and Manufacturing organization.
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Understands the opportunities and challenges in implementing biomarker and diagnostic technologies in a preclinical and clinical setting, including understanding of drug discovery and development in both early and late-stage development and familiarity with the regulatory approval process.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In addition, there is the management of organizational systems and workflow, continuous quality improvement, fiscal management, and departmental goals and programs for the Office of Decedent Affairs.
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As SIRUM's first Legislative Affairs Director, you'll lead SIRUM's policy efforts across the country and be an integral part of shaping new drug donation policies nationwide. You have 3-5+ years of experience in legislative affairs, government affairs, and/or public policy (prior experience in healthcare or pharmaceutical policy strongly preferred.
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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Regularly inspect study document to ensure ongoing regulatory compliance.
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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Foster close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Research, Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
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Identify plant construction safety hazards and hazard mitigation strategies associated with regulatory compliance and accepted consensus standards for large scale hydrogen generation plants. Help plan and participate in EHS compliance audits working cross functional, assessing compliance with EHS standards and local/regional regulatory requirements.
$208,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The student will also have limited exposure to cross functional departments including Clinical Development, Marketing and Market Access, Pharmacovigilance, Regulatory and Development, and various commercial facing field roles.
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Massport’s Capital Programs & Environmental Affairs Department is dedicated to advancing the vision of transforming our industry through groundbreaking approaches, consistently delivering "best-in-class" infrastructure projects that create exceptional value and surpass the expectations of our valued clients and customers.
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Shepherd our electrical ground support equipment through regulatory approval in the U.S. and abroad; examples include field listing or factory listing of power handling equipment. Ability to engage external stakeholders, such as regulatory bodies and various Authorities Having Jurisdiction (AHJs) to obtain necessary approvals for the project.
$91,400 - $140,900 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs. + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs.
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regulatory affairs jobs Title: sr director Company: Planet Pharma in Redwood City, CA
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