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Position SummaryThis 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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Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture. Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
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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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Work collaboratively with key stakeholders such as EHSS, Regulatory Affairs, Medical Safety, Pre-clinical Safety, CMC, Legal and Business Development. Experience in critical evaluation of occupational safety information from multiple sources, including in vivo, in vitro toxicological studies, pre-clinical and clinical studies.
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Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams and as a deputy to the Director, Regulatory Affairs CMC in various internal and external meetings – representing Regulatory CMC as needed.
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Collaborates closely with cross functional teams, including R&D, Technical Operations (Pharmaceutical Development, Manufacturing, CMC, Supply Chain), Regulatory affairs, Pharmacovigilance, to ensure seamless integration of quality standards throughout the product lifecycle.
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Leads development and execution of multi-year global medical strategy for Neuroscience TA, appropriately aligned with overall GM strategy and cross-functional partners in R&D and GPD (Clinical, Regulatory, GEO, PV, GPLS, HEPA, MPD, and Regions.
$481,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the SVP, Head of Regulatory Affairs, this role will have significant strategic oversight of various submissions and will be the global regulatory lead for assigned programs for the company.
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They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Minimum of 5+ years of experience in a Regulatory Affairs for medical devices and drug-device combination products.
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Familiar with regulatory affairs in the beauty industry. Mange the claims process end-to-end, build comprehensive claims support plans, drive the execution of the plans, and identify claims risk with support from R&D, Legal and Regulatory Affairs.
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Build effective and lasting relationships with cross functional partners including but not limited to Clinical Science, Regulatory Affairs, Data Management, and Biostatistics, to ensure alignment and successful execution of defined strategies for assigned programs/protocols.
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This role reports to the Regulatory Affairs Project/Program Manager and works closely with research teams across the Cancer Center and MGB hospitals to ensure regulatory compliance for multiple trials.
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The Legal, Corporate Administration, Regulatory Affairs, and Security (LCARS) Program Management Office (PMO) drives the successful execution of projects in State Street's Legal, Regulatory Affairs, and Global Security divisions.
$132,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with Engineering, Quality, Manufacturing, CM/OEM, Marketing, Regulatory Affairs, and other key functions to achieve business goals. Job Title - Principal Electrical Engineer Job Location - Boston, Massachusetts (Fully Onsite) Type: W2 contract Job Description: Demonstrated capability/understanding of the design and development of medical devices including electro-mechanical assemblies, mechanisms, metal and plastic components, and manufacturing processes.
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Collaborate with cross-functional teams including hardware engineering, quality assurance, regulatory affairs, and product management to define software requirements and project milestones.
$180,000 - $200,000Full-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs in Boston, WA, Ohio
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