法规专员-上海
Apply now »Date: Dec 16, 2024
Location: Shanghai, Shanghai, CN, 201203
Company: Merck KGaA Darmstadt, Germany
与我们携手施展你的超能力!
探索未知、打破壁垒、勇于发现,你准备好了吗?你有宏图大志正待实现,我们同样雄心勃勃。我们遍布全球的员工热爱科技创新,以医药健康、生命科学和电子科技领域的解决方案,切实改善人类生活。我们怀揣远大梦想,热忱关爱员工、客户、患者和人类居住的这颗星球。因此我们一直在寻找永葆好奇心的你,与我们一路同行、敢想敢做,把不可能变为可能!
Role:
- Carry out all necessary work to ensure the efficient and timely submission for API/Excipient and IVD/medical device products application, including new registration/ supplementary/ change application/ annual report etc. Coordinate with global/regional regulatory counterpart to collect information required during the process.
- Maintenance the specific registration management system.
- Monitor regulation development and participants in local association activity if necessary.
- Support local business on daily basis request.
- Other relevant works to support the team. e.g. support on ChP project, sample management, Regulatory intelligence project and so on.
Job-specific Competencies & Skills:
- Good communication with multi-departments
- Favorable organizational and time management skills.
- Ability to work in multi-cultural teams.
- Proficient in MS Office Software (word, Excel, PowerPoint etc)
- Proactive attitude towards work
Background:
- Bachelor’s or graduate degree in pharmaceutical related major
- 10 years relevant experience in Regulatory affairs is preferred
- Fluent in spoken and written English
- Good understanding in regulatory operations area
我们能够提供:我们对未知充满好奇,我们的员工有着多样化的背景、多维度的视角和个性化的经历。作为一家前沿科技企业,我们欣赏全方位的多元性,坚信这能驱动卓越和创新,从而强化我们“科技先锋”的底色。同时我们致力于为所有员工提供机会和资源,支持他们按各自的节奏充分成长和发展。加入我们,共建充满包容性和归属感的企业文化,让每一位志同道合的伙伴能够施展自己的超能力,共同推动人类迈向进步的未来!
立即申请,成为我们多元化团队的一员!
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