岗位描述摘要：

该职位将担任法规事务部运营专员，与业务部门、全球法规事务部、工厂和其他职能部门合作，支持法规事务部的运营工作。

主要职责：

1.    与本地法规事务部、全球法规事务部、业务部门及工厂密切合作，根据法规和公司要求通过Artis系统管理产品标签、说明书以及包装。

2.    与业务、法务、合规等部门同事合作，管理公司数字资产平台 Veeva PromoMats，维护和修订本地 SOP，培训和支持本地系统用户，并从从法规事务部的角度审核批准市场推广材料。

3.    与全球法规事务部、工厂及进口代理进行沟通，进口注册用样品、试剂和耗材等。根据进口相关法规，管理进口工作流程，确保样品可以及时进口。

4.    药物安全警戒指定联络人的后备支持人员，支持药物安全警戒指定联络人 D管理本地药物安全警戒的质量管理系统，以遵循本地法规和公司政策。

5.    管理层分配的其他任务。

任职条件：

  硕士学历，基础兽医学 、预防兽医学或其它相关学科优先。

  有1到3年在制药或生物制品公司从事研发、质量管理或兽医技术服务者优先。

  英语流利，沟通能力强，工作积极，乐观向上，诚实正直，善于自我激励和承受压力。

工作地点：北京

简历发至：msdahpv@merck.com

Job desc：

The position will serve as RA (operation) specialist to work collaboratively with commercial marketing, global regulatory affairs, manufacture sites and other functions to support regulatory affairs.

Key responsibilities:

1.    Work closely with local RA, GRA, commercial teams and manufacture sites to manage product label, package through ARTWORK according to the regulation and company requirements.

2.    Collaborate with commercial marketing, legal, compliance colleagues to manage Veeva PromoMats, the company digital assets platform. Maintain and revise local SOPs, train and support local end users, review and approve promotional materials from RA point of view.

3.    Support RA to communicate with Global colleagues and import agency to import samples and reagents. Update importation relevant regulations and mange import workflow to ensure that samples could be imported timely.

4.    Conduct PV responsibilities as PV backup to support PV DPOC manage local PV QMS by following local regulations and company policies.

5.    Other tasks assigned by management.

Education:

Master degree,

Major in veterinary pharmacological or Biological

Experience:

?   1-3 years of regulatory affairs experience in pharma or bio products, or R&D, QA , technical support on veterinary production.

Skills, abilities and other requirements:

?   Proficient in English

?   Knowing to learning

?   Drive results

?   Good communication skills