北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京药品注册招聘

Regulator Affairs Manager

赛诺菲(北京)制药有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2021-01-11
  • 工作地点:北京-朝阳区
  • 招聘人数:1人
  • 工作经验:8-9年经验
  • 学历要求:本科
  • 职位月薪:3-4万/月
  • 职位类别:药品注册

职位描述

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

- Have broad presence and resources within large scale international trials and strong new product pipeline

- Copperate with strong, independent technology group and experience digital & innovative ways of working

- Be viewed as a trusted partner, shared goals and quality work

What you can contribute?

Contributing and facilitating regulatory strategy for the responsible projects with the guidance of senior regulatory manager,and being accountable for HA interaction for regulatory strategy assessment

Being accountable for the regulatory strategy implementation by CTA / NDA submission / approval

Being accountable for the LCM mantainance of marketed in China and provide regulatory support for QC testing to secure commercial supply

Leading regulatory operations for the assigned products in China

Working with related functions to support business timely

What you should have?

Bachelor’s degree or above in clinical medicine or pharmacy

>=5 years in RA experience and industry experience

Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines

Good command of English (written and spoken)

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

Team player with good communication, negotiation and influencial skills

Good planning, organization, strategic thinking and leadship skill


职能类别:药品注册

公司介绍

集团概况

尊重:我们认同和尊重员工、患者和合作伙伴的需求及其多样性。我们承诺在互信的基础上开展透明且具有建设性的沟通。

创新:我们鼓励所有的员工和合作伙伴发挥创业精神、探索创新思路。

信心:我们充满自信,恪守原则。我们一心一意、永不气馁,敢于挑战常规。

齐心:我们对我们的行为、我们的员工、我们的患者和我们生存的环境负责。共同的责任让我们走到一起。

正直:我们承诺,坚持最严格的道德操守和质量标准,决不妥协。

赛诺菲(北京)制药有限公司
赛诺菲(北京)制药有限公司坐落于北京经济技术开发区,占地4万多平方米,现有员工100名左右。公司于2002年12月通过了国家GMP认证,认证范围包括小容量注射剂的分包装,片剂和胶囊的分包装和生产。公司产品于2003年3月开始投放国内市场。

联系方式

  • 公司地址:地址:span亦庄经济技术开发区兴盛街7号