for submission in the relevant countries. Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified...
CK Groupfor submission in the relevant countries. Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified...
CK Groupand manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans... interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment. Plan...
CK Groupand manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans... interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment. Plan...
CK Groupis responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions... to current regulatory requirements and expectation for biologics/cell therapy marketing applications, clinical trial applications...
Bristol-Myers Squibbsuccessful candidate has experience in drug-development process, clinical study lifecycle, regulatory compliance, and the uses of real... strategic planning and execution of evidence generation initiatives to support product development, regulatory submissions...
Gilead