太仓招聘

职位描述：
岗位职责：
1、负责组织公司全部生物药项目的注册申报工作；
2、申请资料的技术审核及资料提交，跟踪注册项目的审批进度；
3、及时掌握药品注册政策的变化情况，并同相关部门保持良好的联系，建立和维护药品注册相关主管部门和专家资源体系，推进已申报品种的注册进展；
4、推进药品注册申报工作，及时掌握注册药品的最新动态，及时与相关人员沟通并协助完成补充资料；负责协调CFDA专家及药学专家，解决药品研发及注册过程中的法规和注册问题；
5、承担注册政策法规宣传任务，为公司提供政策法规信息的支持和培训；
6、协助处理国家、省市药监局、质监局、药检所等上级部门相关事务；
任职要求：
1. 专业要求：药学/药事法规相关专业硕士及以上学历（注册实际经验丰富者可以放宽要求）；
2. 工作经验要求：有8年以上药品注册申报工作经验；参与过至少2个生物药以上项目资料整理和撰写工作；
3. 熟悉药品注册、技术研究等行业政策法规；
4. 具有较强的沟通协调、团队协作、时间管理、学习及抗压能力；
5. 工作责任心强，细致严谨。 举报 分享

BurmingNash Consulting is a leading professional recruitment consultancy, offering Executive Search, Contingency Recruitment and RPO services in Asia Region.

Our services include a range of recruitment solutions tailored to meet the needs of both Foreign- and Chinese- owned organizations, across a diverse portfolio of industry segments.
Our reputation has been built upon delivering outstanding results and exceptional service levels.
Our consultants are subject matter experts in their chosen fields, they are experienced, thoroughly trained and, importantly, passionate about their specialist fields.
Our Sectors:
* Medical Devices;
* Pharmacy;
* Intelligent manufacturing/ Robotics / AI / 3D Printing/ AR / UAV/ Home Automation/ Autonomous Vehicle Intelligence Logistics

We are confident that our expertise can add value to your recruitment or job search process – get in touch to find more.
Michelle.dong@burmingnash.com.cn ; + 86) 21 52991611 # BurmingNash 博明纳仕 #