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This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Assist the Director/Associate Director in assuring Novo Nordisk compliance with internal SOPs and global regulations, including compilation and submission of any required documents to regulatory agencies.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Associate Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Regulatory Affairs Specialist. Cybersecurity Policy Program Director - Global Regulatory Affairs, Strategy, and Policy.
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In coordination with the CMO and ACMO / VP of Quality, manage the Quality Committee of the Board•Serve as on-site physician executive in support of embedded enterprise team members for clinical compliance, risk management, and patient safety, including conduct of safety event evaluations and mitigation, and Joint Commission surveys and other regulatory site visits and inquiries (DPH, BPHC, etc.
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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs.
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Serve as on-site physician executive in support of embedded enterprise team members for clinical compliance, risk management, and patient safety, including conduct of safety event evaluations and mitigation, and Joint Commission surveys and other regulatory site visits and inquiries (DPH, BPHC, etc.
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As part of the legal team, the Associate General Counsel will be called upon to offer legal advice and strategy on a wide variety of matters throughout the agency pertaining to the regulatory oversight of casino gaming, sports wagering, horse racing, and other matters under the Commission's purview.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials.
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You may also assist in the development of new regulations, as well as the review of the environmental and cost impacts of proposed activities, legislation, and policies before the State legislature, Executive Office of Energy and Environmental Affairs (“EEA”), and the DPU; and make recommendations to the DPU regarding its involvement and intervention.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development.
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Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies. The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
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regulatory affairs associate jobs in Cambridge, MA
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