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负责CMC团队的建立、完善和管理;制定原料药和制剂的开发策略和生产计划;指导解决新药工艺开发过程中的关键技术问题;负责管理外包研发生产服务供应商;负责与监管部门在CMC方面的沟通和交流;配合临床部门开展临床试验,提供药学方面的支持;配合注册部们完成各项目IND/NDA申报资料的撰写、审查,配合完成现场核查及注册申报。
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