负责与化学,制造和控制(CMC)特别相关的监管活动。活动,如准备和出版REG CMC文件,以提交给卫生当局。此外,还就REG CMC问题与HA进行互动,以支持新产品或上市后发布。
About The Role
Major Accountabilities
~ 凭借丰富的监管专业知识,以创新为重点,制定、领导和推动全球CMC监管战略,在平衡监管风险和合规性的前提下,最大限度地提高业务效益。
~ 领导并推动针对指定项目/产品的一切全球CMC提交活动(计划、编写、审查、协调、提交),同时将全球战略应用到提交中。
~ 确定全球提交所需的文件和任何内容、质量和/或时限问题,并根据项目时限磋商获批准的技术源文件的交付事宜。
~ 制定和使用CMC全球监管战略、当前监管趋势和指南,编写和/或审查针对卫生局提交的高质量CMC文件。
~ 在整个生命周期内,及时主动向项目团队和其他利益相关方传达CMC监管策略、风险和关键问题。
~ 领导、编制和传达CMC风险管理评估、应急计划以及在重大提交事件中汲取的教训,并酌情上报。
~ 发起并领导卫生局的互动和谈判;设定目标、编制简报、协调和计划演练以及降低风险计划。
~ 通过专门部署,在部门内及跨职能部门间提供战略建议和指导。
~ 与RA CMC部门经验不足的成员分享监管知识。
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发(如适用)
Key Performance Indicators
负责与化学,制造和控制(CMC)特别相关的监管活动。活动,如准备和出版REG CMC文件,以提交给卫生当局。此外,还就REG CMC问题与HA进行互动,以支持新产品或上市后发布。
Work Experience
~运营管理和执行
~项目管理
~跨界协作
~职能广度
~跨文化经历
~管理危机
~关键谈判
Skills
~变更控制
~药物开发
~生命科学
~谈判技巧
~药物
~产品生命周期管理 (PLM)
~法规遵从性
~风险管理
~项目管理
Language
英语
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