[外包]法规专员（生物方向）-知名外资-北京-13K

Job Title: Regulatory Affairs Specialist – Contractor

LQ97p?'e 

Job Responsibility

l   Responsible for animal by-products (Abp) and biologics special products regulatory compliance. Include but not limit to,

2  Coordinate documents preparation for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan. For example,

1.        Apply for related import permits, e.g. Animal and Plant Import Permit, Sanitary Permit etc.;

2.        Communicate with related local and global departments for information and document request, such as ManDec (Manufacturing Declaration) request, VC (Veterinary Certificate) request, etc.;

2  Keep good connection with local authorities (AQSIQ, local CIQ), monitor Abp prohibition list and other Abp relevant regulation issued by AQSIQ and local CIQ regularly, inform internal stakeholders about regulations with impact to business.

2  Timely and effectively communication with global regulatory management team, Import & Export team and related business team regarding import check, import permit progress, customs clearance, regulatory risks with impact to business, work on mitigation plan to ensure compliance.

Ÿ   Responsible for cell lines import regulatory compliance. Include but not limit to,

Ÿ   Responsible for import permit application for trehalose and insulin products.

l   Responsible for electrical safety compliance for hardware.

l   Miscellaneous administration works related with daily regulatory management

Y M-=i 

Requirements:

l   Bachelor’s degree with biological science related background.

l   With experience of AbP products and biologics special products import permit application, 1～3 years.

l   Strong data compilation and multi-tasks management capability.

l   Good in learning and communication skills with teamwork manner.

l   Fluent in Chinese & English (read and written) is required.

l   Very good Microsoft skill.

TkHz Ul 

需要生物相关的背景，英语书面就可以，不一定要RA或进出口的经验，但是必须生物相关的专业背景，如果是生命科学相关专业更好

/5/}Dng 

工作地点：北京市朝阳区曙光西里甲5号院凤凰置地广场A座写字楼18层（东城、朝阳、海淀）

薪资福利：月薪9-13K+13薪+绩效奖金+五险一金+节日福利+免费体检+补充医疗保险等等

r/vkk 

有意者请将简历发至tong.chaoqun@fescoadecco.com（注明来自HR圈内招聘网）