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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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The Senior Director, Regulatory Affairs will drive global Regulatory strategy for the Spur product development portfolio, advancing clinical stage programs in the gene therapy arena.
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Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization.
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Lead the execution and evolution of the integrated launch plan, coordinating with supply chain, regulatory affairs, market access, HEOR, medical affairs, and other functions. As a pivotal member of the rare disease team, the Global Marketing & Commercial Lead for Rare Disease will report to the General Manager and drive the execution of a robust commercial strategy for our portfolio, initially focusing on PA and MMA. This strategic role requires collaboration with multidisciplinary teams across R&D, Medical Affairs, Value and Access, and Supply Chain to ensure cohesive efforts within Moderna.
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Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Demonstrated track record in leading cross-functional teams and workstreams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs). Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
$151,000 - $246,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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The VP CMC Regulatory & Quality will lead all aspects of CMC Regulatory Affairs to support global regulatory submissions as well as CMC Quality Assurance and Quality Control for Invivyd’s clinical candidates and commercial products.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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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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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine’s/Vertex network of external CMOs/contract labs to support company’s clinical programs.
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The Legislative Affairs co-op will report directly to the Chief of Intergovernmental Affairs, and work as part of the Legislative Affairs Team to support their ongoing projects. Learn day to day activities of a Legislative Affairs/Intergovernmental operations.
$20 an hourFull-timeExpandUpdated 1 month ago
regulatory affairs record keeping jobs Title: regulatory affairs coordinator in Cambridge, MA
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