Responsibilities and Requirements: 6+ years' experience of Regulatory Affairs product labeling in the... from scientific source data and regulatory requirements. Experience with labeling deviations, new indications, safety updates...
with GRST. Propose approaches to resolve regulatory issues and appropriately drive speed to patients. Lead and/or support... guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical...
for development programs. Marketed products, including the coordination of global labeling activities according to regulatory... requirements and company standards to ensure timely and compliant regulatory submissions worldwide . Regulatory Labeling...