Senior Regulatory Affairs Associate at Xpheno | Torre

Senior Regulatory Affairs Associate

You'll shape global biologics and vaccine development through expert regulatory submissions.
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Full-time

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Shared by
Juan Palo Rodriguez Montoya
9 days ago

Requirements and responsibilities


Are you passionate about global regulatory submissions and biologics development?We are looking for a Regulatory Affairs professional with experience in biologics, vaccines, biosimilars, monoclonal antibodies, and recombinant proteins.Expertise in MAA/BLA submissions, CTD dossier preparation, lifecycle management, and CMC regulatory activitiesExperience working with global regulatory agencies including FDA, EMA, PMDA, Health Canada, Swissmedic, and TGAOpportunity to work on innovative biologics and vaccine portfolios in a global, cross-functional environment.
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