CMC Regulatory Affairs IgMAX Regulatory CMC strategy Team Lead will provide leadership and be the Regulatory CMC point of contact for major projects in the Plasma OpU, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization of manufacturing. Include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3.
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