• 招聘类型：社招
• 工作性质：全职

职位描述

Job Description

1、Responsible for managing the marketing operation of the Group's export product in Europe, including obtaining and filling the orders, delivering the product overseas, and handling post-sale service as well as customer complaints (if any).

2、Responsible for new business development in Europe and the US for the Group's CMO business.

3、Responsible for monitoring the daily operation of OY Simcere in Europe.

4、Responsible for regulatory affairs regarding the existing export product in Europe, including maintaining the registration files, drafting and filing amendments, preparing and submitting annual regulatory reports and handling the renewal of marketing authorization, etc.

5、Responsible for maintaining the EU GMP certificate, ensuring EU/FDA GMP compliance, receiving foreign GMP inspections and communicating with foreign regulatory agencies with regard to GMP compliance-related issues. Provide technical guidance to internal employees to ensure EU/FDA GMP compliance.

任职条件

Requirements

1、 BS degree or above in pharmaceutical science, engineering, chemistry, or related majors.

2、 3+ years of working experience in pharmaceutical companies in Europe or the US. Or 5+ years of working experience in the China branch of EU or American pharmaceutical companies.

3、 Working experience in any of the following areas: overseas business development, marketing, EU/FDA regulatory affairs, or EU/FDA GMP compliance. Hands-on experience in EU/FDA GMP inspection and regulatory registration is a plus.

4、 Able to travel frequently in China and overseas.

5、 Excellent business English skills. "

职位要求

• 学历要求：本科
• 工作经验：无
• 外语要求：不需要