RA CMC Manager

Job description -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. read more Key Skills Operations managementPublishingNetworkingProject documentationProject managementRisk assessmentRegulatory complianceCMCRisk managementRisk mitigation