Regulatory Affairs Jobs in Somerville (MA)
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Search Results - Regulatory Affairs Jobs in Somerville (MA)
ArtechSomerville (MA)
emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs...
Genetix BiotherapeuticsSomerville (MA)appcast.io
ensures full regulatory compliance with FDA/EMA/ICh guidelines in a virtual operating model, coordinating with Manufacturing, Regulatory Affairs, Medical, and Supply Chain teams to sustain patient supply and inspection readiness.
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AstraZenecaSomerville (MA)
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At AstraZeneca, we do this with the upmost integrity even in the most...
Genetix BiotherapeuticsSomerville (MA)appcast.io
Supply Chain, Regulatory Affairs, Medical, Patient Operations, and Commercial teams to ensure uninterrupted and compliant patient supply, timely quality decisions, and sustained inspection readiness as the organization scales.
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External...
Alnylam PharmaceuticalsSomerville (MA)
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies...
Intellia TherapeuticsSomerville (MA)jobvertise.com
development through commercialization, and partners with QA GMP Operations, Global Technical Operations, Process Development, Regulatory Affairs, and external testing laboratories/CMOs.Responsibilities:Provide quality and technical oversight and governance...
Alnylam PharmaceuticalsSomerville (MA)
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy...
Genetix BiotherapeuticsSomerville (MA)appcast.io
closely with:
• Clinical Development
• Medical Affairs
• Technical Operations and CMC
• Quality Assurance
• Commercial and Market Access
• Legal and Compliance
• Serve as a trusted advisor to executive leadership on regulatory opportunities...
AstraZenecaSomerville (MA)
Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid andeffective submissions, approvals and other product maintenance activities· Participates in skill-development, coaching, and performance...
Beam TherapeuticsSomerville (MA)
committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality...
Alnylam PharmaceuticalsSomerville (MA)
and executing the technology strategy supporting Regulatory Affairs, Regulatory Operations, and Medical Writing. This role serves as the primary business technology functional leader for these teams, ensuring that platforms, data, content capabilities...
Alnylam PharmaceuticalsSomerville (MA)
but realistic approaches to drug development and lead clinical efforts towards global regulatory approvalsOversight of trial conduct and safetyCollaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration...
Alnylam PharmaceuticalsSomerville (MA)
of all clinical development programs and marketed RNAi therapeutics. In this role, you will work closely with Clinical Research, Global Patient Safety and Risk Management (GPSRM, Regulatory Affairs, and Biostatistics, to inform clinical development...
Beam TherapeuticsSomerville (MA)
Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality.Responsibilities:Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s).Provide PV subject matter...
Biogen IdecSomerville (MA)
technologies, and partnering with internal and external stakeholders to advance optimized delivery systems for Biogen’s pipeline.This position requires strong collaboration across Device Development, Human Factors, Packaging, Manufacturing, Quality, Regulatory...
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