南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京药品注册招聘

Regulator Affairs Manager

赛诺菲(中国)投资有限公司

  • 公司规模:5000-10000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:2021-01-12
  • 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

赛诺菲-安万特的愿景是:满足患者的需求,成为全球领先的多元化医药健康企业。

赛诺菲-安万特集团的疫苗事业部,即赛诺菲巴斯德,是全球***的专业致力于人用疫苗研发和生产的企业。

赛诺菲-安万特拥有近11万名员工,分布在110多个国家。公司在医疗保健领域实力雄厚,业务遍及全球,是疫苗、生物制药产品的市场领导者,并在新兴市场运营多年,日益壮大。

此外,公司业务范围还包括健康药业产品,仿制药和动物保健产品等。

赛诺菲-安万特是首批在中国开设办事处的跨国制药集团之一,同时也是国内增长最快的医药健康企业之一。集团在疫苗和众多关键的治疗领域拥有领先产品,目前,赛诺菲-安万特在国内200个城市有逾4,500名员工。

赛诺菲-安万特分别在北京、杭州和深圳设有生产基地。2007年,集团投资9,400万美元(人民币7亿元)在深圳兴建高科技生产基地,以生产季节性流感疫苗凡尔灵,并帮助中国应对流感大流行。

2008年10月,赛诺菲-安万特宣布了中国研发规模扩展计划,以加速各临床项目(从药物靶点发现到后期临床研究)的发展。

2009年4月,赛诺菲-安万特宣布增资9千万美元(人民币6亿元),在北京工厂建设灌装生产线。

同年4月,赛诺菲-安万特宣布斥资人民币4.1亿元(4,400万欧元)在杭州滨江高新技术产业开发区打造新的生产基地,以代替位于杭州市区的工厂。新厂将采用***和设备,成为赛诺菲-安万特(中国)面向其它亚洲国家的出口基地。

2009年10月,赛诺菲-安万特旗下动物保健事业部梅里亚集团宣布投资7千万美元扩建其江西南昌工厂。该厂为中国国内市场提供禽用疫苗。梅里亚动物保健有限公司在中国已有近20年的发展历史。

2010年1月,赛诺菲-安万特与杭州民生药业有限公司签订正式交易合同,共同组建一个新的健康药业领域合资企业。取决于交易相关先决条件和政府部门批准,赛诺菲-安万特将在该合资企业中占多数股权。

联系方式

  • 公司地址:地址:span南京