公司：外资医药生物科技公司
工作地点：武汉
Job Responsibilities：
1. Key strategic role for all JHL regulatory activities to meet CFDA requirements for internal and external projects. Develops and provides direction and prioritization in regulatory affairs, registration and documentation in China.
2. Accountable for interactions with CFDA.
3. Ensure a consistent approach for CFDA regulatory activities for the JHL development portfolio that meet business needs and objectives while taking into account the global regulatory environment. Communicate between departments to provide regulatory support in ensuring CFDA standards are met. Assist in internal and cross-functional regulatory policy development. Provide regulatory support for relevant quality systems and inspection management.
4. Support the preparation (writing, review, and compilation) of all necessary documentation to support technical content of CFDA regulatory submissions and other relevant regulatory documentations.
Job Requirements:
1. PhD degree or equivalent in a scientific discipline
2. 10+ years of experience in the core activities of Regulatory and in leading projects that have successfully brought molecules to China market
3. Strong knowledge of the regulatory environment including interactions with CFDA
4. Knowledge of FDA, EMA, CFDA regulations, ICH guidelines are required
5. Scientific writing and editing skills are essential
6. Experience and strong understanding of Research and Early Development in biological product
7. Excellent verbal and written communication skills; communicate in Mandarin/English is requirement
8. Strong ability to work both independently or collaboratively in a team structure, including a proven ability to work well under pressure
9. Biosimilar experience a plus.
10. Hands on experience in process development is a plus.
简历可发至：wanco@wanco.com.cn，并写上要应聘的职位名称。
上海万谷境外就业服务有限公司
Shanghai Wanco Overseas Employment ServiceCo., Ltd
电话：+86-21-62946951/62946952
网站：www.wanco.com.cn
邮箱：wanco@wanco.com.cn
QQ: 800066950(搜服务)
微信号：wancoshanghai
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