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... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy ... Therapy Development Organizations to ensure regulatory compliance of GMP operations in ... manufacturing sciences and technology, and..
About AbbVieAbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on ..
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Job Summary: The Regulatory Operations Sr. Manager, Publishing will lead and manage ... for the preparation of global regulatory submissions. This position will collaborate ... position will collaborate closely with..
... DESCRIPTIONAs a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics ... responsible for establishing the overall regulatory strategy for contemporaneous development of ... will serve to develop a..
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were ..
... to help patients. OverviewBioMarin Global Regulatory Affairs (GRA)u00A0is responsible for obtaining ... as the interface between the regulatory authorities and the program teams ... plan correctly anticipates what the..
... lives. Responsibilities Analyst role for Regulatory Research & Intelligence (RRI) includes: ... Intelligence (RRI) includes: Supporting senior regulatory research staff involved in examining ... research staff involved in examining..
... development activities including preparation of regulatory submissions for the target clinical ... CRO management, clinical support of regulatory interaction, and study analysis and ... and reporting). Partner with Research,..
... on patientsu2019 lives. SummaryThe Senior Manager supports Regulatory leadership in the development and ... of global nonclinical / clinical regulatory strategies through a programu2019s lifecycle.u00A0 ... through a programu2019s..
... preparation, and submission of CMC regulatory documentationThis includes supporting the global ... CMC strategy for the Global Regulatory Plan, with input from regional ... Plan, with input from regional..
... Clinical Development, Clinical Science, Research, Regulatory Affairs, Biometrics, and Quality Assurance. ... and documentation for submission to regulatory agencies (IND, BLA). Develop and ... counterparts in Early Development, Research,..
... and execution, data analysis and regulatory filings as delegated by the ... components of trial execution and regulatory submission (including IND Annual Reports, ... treatment, drug development trends, and..
