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The successful applicant will operate at an extremely fast pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development experts.
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This role will work with a wide variety of clients, from local manufacturers to complex Federal design projects supporting the mission of such agencies as the U.S. Department of Veteran Affairs, U.S. Army Corps of Engineers, and others.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Specific domain knowledge of biotech lab processes, biological systems, and regulatory standards. FL97 is seeking a dedicated and skilled (Sr.) Automation Engineer to join our team. Flagship has created over 100 groundbreaking companies since 2000, including Moderna (NASDAQ: MRNA), Generate Biomedicines, Tessera Therapeutics, Indigo Ag, Inari Agriculture, and Sana Biotechnology.
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The Program Leader will lead a cross-functional matrix team consisting of functional representatives from clinical development, clinical operations, regulatory affairs, translational medicine, clinical pharmacology, clinical biomarkers, CMC, non-clinical sciences, and medical affairs to deliver against an ambitious program strategy.
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Experience in bioanalytical assay development and qualification based on regulatory guidelines. Preparing RNA and proteins from cell or animal samples and analyzing these samples by qPCR, ELISA, MSD, next-generation sequencing, or Western blot analysis.
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Be ready to participate in quality systems, engineering, mfg, regulatory activities, etc. knowledge of manufacturing processes such as plastic injection molding, ultrasonic welding, etc. The job responsibility will primarily include developing, designing, troubleshooting manufacturing SOP's, and microfluidics based systems.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. We are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform method development and qualification for lot release and characterization of cell and gene therapy products and critical materials.
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Must understand drug development stage gates, including preclinical, clinical phases, and regulatory milestones. Familiarity with regulatory requirements and compliance standards relevant to portfolio management, including SEC regulations and industry best practices.
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Knowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related function. Knowledge of regulatory and compliance guidelines governing medical affairs.
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Ensure the development and execution of strategic and functional plans and facilitate processes to ensure all Medical Affairs programs and activities are aligned with business strategies and legal and regulatory guidelines.
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You will have close liaison with Clinical Affairs, Global Education, Regulatory, Quality, Marketing & Business Development and R&D colleagues, as well as dialogue with key opinion leaders and healthcare providers.
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Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept byArticulating clinical development strategyAnalyzing, interpreting, and acting on clinical trial data to support developmentServing as principal functional author for Regulatory submission, study reports, and publications.
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Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally. Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF.
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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs.
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regulatory affairs jobs Title: sr regulatory affairs in Lexington, MA
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