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

Regulatory Affairs Manager

爱恩康临床医学研究(北京)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:2021-06-03
  • 工作地点:北京-朝阳区
  • 招聘人数:2人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 职位月薪:2.5-3.5万/月
  • 职位类别:药品注册

职位描述

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance.

Responsibilities
? Adherence to sponsor and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
? For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.
? Maintain product licenses in assigned portfolio through timely renewal to a high standard.
? Maintain the awareness and shape the regulatory environment relevant to the assigned portfolio.
? Actively develop excellent relationship with local regulatory authorities and external stakeholders.
? Drive issue Management.

Requirements
1. Bachelor or above in Pharmacy, Medical, Biology or related field.
2. Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
3. Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
4. Project management primary level skill
5. Chinese and English (proficiency level)

职能类别:药品注册

公司介绍

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

联系方式

  • Email:sarah.ma@docsglobal.com
  • 公司地址:北京市东城区北三环东路36号环球贸易中心 (邮编:100013)
  • 电话:18810965020