Regulatory Affairs Specialist(职位编号:26596)
上海任仕达人才服务有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2015-04-15
- 工作地点:北京
- 招聘人数:2
- 工作经验:1年
- 学历要求:本科
- 职位月薪:面议
- 职位类别:药品注册
职位描述
Contact us to start your exciting career development in a collaborative, dynamic and stimulating work environment in Fortune 500 multinational pharmaceutical company.
Responsitilities:
1. Ensure the testing timeline was achieved;
2. Ensure the new products application, license renewal and variations registration is managed according to the timeline specified in the reporting period.
3. Bridge clear, adequate and effective communication with global RA to ensure China requirements and processes are well understood;
4. Support business post-market needs, including but not limited to label & IFU review, port testing support and etc;
5. Maintain the close working relationship with CFDA, testing labs and other government agencies;
6. Business & regulation acumen; provide professional solution to support sustainable business growth;
7. Set up and maintain regulatory database in an efficient manner;
8. Set up and maintain an approachable dossier archive system; make sure all dossiers submitted to agency was retained according to company policy;
9. Support team daily operation including but not limited to sample management, contract & payment coordination, set up team & cross function meeting.
Job Requirements:
1. Bachelor degree in pharmacy or related science;
2. Over 1 year working experience in pharmaceutical industry (RAspecialist);
3. Good management of time;
4. Fast learning capability;
5. Good written English.
公司介绍
联系方式
- 公司地址:梅园路77号
- 邮政编码:200070