Associate Director Cmc Regulatory Affairs Jobs

... 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,..

... 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..

Sr. Director, Regulatory Affairs CMC n n nThis position is ... position is responsible for the CMC strategic regulatory direction, interactions with U.S. and ... interactions with U.S. and international..

... 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..

... 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..

... Purpose and Scope: The Senior Associate, CMC Regulatory Affairs (RA) is responsible to support ... (RA) is responsible to support CMC regulatory activities for our company's products ... content..

... 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..

... Therapeutic Area Head Support the Regulatory Affairs Therapeutic Area Head for IN&F ... leading and developing the global regulatory strategies, overseeing health authority interactions ... hiring, retention, and development..

... 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..

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,..

... 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..

... Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development ... Therapy Development Organizations to ensure regulatory compliance of GMP operations in ... WA and reports to..