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We serve as key strategic partners for commercial, regulatory, R&D, market access and external affairs to develop and launch first in class and best in class therapeutic solutions that address highest unmet needs.
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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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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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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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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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Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis. Additional responsibilities will include preparation and review of analytical CMC documentation, contribution to authoring and review of analytical sections of regulatory submissions.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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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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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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Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally. Reports to: Associate Director or Director of Clinical Operations.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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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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Familiarity with Applied Behavior Analysis and competency in the implementation of fundamental procedures as described in Epic’s training protocols and any regulatory or funder requirements (e.g., registered behavior technician training.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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Center 3 (19075), United States of America, McLean, VirginiaPrincipal Associate, Data Loss Prevention (DLP) EngineerCapital One is hiring a technical Cyber Security professional to join the Data Loss Prevention (DLP) team and work with the line of business stakeholders building DLP system policies/ruleset based on ongoing regulatory requirements and analysis of user business processes and workflows.
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regulatory job Title: sr regulatory affairs associate in Lexington, MA
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