药品注册实习生
2022-10-19 00:01:56 刷新
150/天 北京 硕士 3天/周 实习3个月 提供转正机会
与大拿工作平台好
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职位描述:

Position Summary

Responsible for the regulatory affairs, submissions support for dMed and its clients, implementing drug registration operation service support as per project needs, such as IND, NDA, lifecycle submissions and healthy authority query response, as well as the submissions-related activity. Maintain good relationship with regulatory authorities for business support. Keep apprised of regulatory developments and understanding key regulatory changes locally and globally. Contributing to dMed internal regulatory intelligence development, documentation system and training program, supporting business opportunities, etc.

Key Responsibilities

  • Ensure required regulatory support for dMed and its clients, implement drug registration strategy plan or operational service as per project and/or customer’s needs
  • Establish and maintain good relationship with regulatory authorities and industry associations for business support and understand key regulatory changes
  • Contribute to dMed internal regulatory intelligence development, documentation system and training program, consultation and support to business opportunities, etc.
  • Education and Key Competency Requirements

  • Master degree in a life or medical sciences or relevant scientific background.
  • Knowledge of ICH Guidelines, local regulations and GXPs including, but not limited in regulatory requirements for the conduct of clinical development programs.
  • Superb organization, communication skills (oral and written in Chinese & English) and strong interpersonal skills to be able to effectively interact with customers, key stakeholders, health authorities, multidisciplinary groups as well as with vendors.
  • Good learning, analytical and issue identification abilities, and attention to detail
  • Creative problem solver and keen ability to address current and anticipated issues
  • Good teamwork spirit and positive working attitude
  • Proficient computer skills
  • Able to travel per business needs
  • 投递要求:
    简历要求: 不限
    截止日期:2022-07-15
    工作地点:
    北京市朝阳区霞光里15号霄云中心B座23楼 收起地图
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    当前职位已下线