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... for the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... functions to prepare and..
... on internal/external system audits and regulatory agency inspections Responsible for business ... research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT). EXPERIENCE/KNOWLEDGE Subject matter ... work well cross-functionally with..
... on internal/external system audits and regulatory agency inspections Responsible for business ... documentation system in compliance with regulatory requirements, company requirements and procedures; ... research, analytical, quality, engineering, manufacturing,..
... who will be accountable for CMC product strategy to enable advancement ... include leading or managing the CMC PST, representing CMC at Vir Program Team meetings, ... alliance partnerships..
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... will Achieve More with Intellia:The Associate Director, Clinical Operations is an integral ... Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and ... Clinical Pharmacology, Clinical..
... Product Quality Lead (Principal PQL), Associate Director of Global Product Quality. The ... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development ... Therapy Development Organizations..
... mastery of the fundamentals of regulatory affairs, the Associate Director will have the key role ... goals. Reporting to the Executive Director, Head of Regulatory Affairs, The Associate Director..
... control to ensure we meet regulatory standards, and procure the needed ... This position reports to the Director, Engineering Quality in Quality Sciences ... as MSAT, Technical Development, QSAT,..
Senior Director, Regulatory Affairs n nThis position is responsible ... overseeing, supervising, and managing the Regulatory Affairs (RA) function. This includes Regulatory CMC, Regulatory Program Management, Regulatory Submissions, Regulatory Information,..
... make a difference. Position: Executive Director, Regulatory Affairs Team Leader Supervisor: Vice President, ... Team Leader Supervisor: Vice President, Regulatory Affairs Department: Global Regulatory Affairs Prerequisites Bachelors in scientific..
... global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing ... the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for ... and..
... diseases. SUMMARY DESCRIPTIONAs a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics and medical ... responsible for establishing the overall regulatory strategy for contemporaneous development of ... will..
