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临床报批主管,Regulatory Affiars

20K-30K/月

深圳市硕士及以上5年及以上30-45岁

发布时间:2019-03-14

职位描述

岗位职责:
(1) Lead and manage the submission of regulatory applications and documents, including responses to information requests, included in the company’s internal or partnered submissions

(2) Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timeless are met

(3) Develop regulatory strategy and provide strategic input and regulatory advice to project teams

(4) Provide critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary. Assure compliance with U.S. and China regulations

(5) Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks

(6) Maintain knowledge of current global regulations, and guidance governing drugs and biologics in all phases of development

(7) Work cross functionally with Clinical, safety, research, quality, manufacturing, product management, etc.

任职资格:
(1) A minimum of a MS in life sciences with at least 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience may be considered)

(2) Demonstrated experience with U.S. submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process. Experience with European/global submissions is a plus.

(3) Experience with oncology indications is preferred

(4) Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the company

(5) Experienced in all components of regulatory submissions including chemistry, manufacturing and control, non-clinical, and clinical documentation is further required

(6) A record of successful U.S. submissions for biologics and drugs which include INDs, NDAs/BLAs, MAAs, Annual Reports, and Amendments

其他要求

  • 1人
  • 研发
  • CEO
  • 普通话、英语
  • 临床监查员CRA

公司介绍

深圳市塔吉瑞生物医药有限公司创建于2014年,是一家中美合资的高科技医药研发公司。公司以挽救病人生命为核心,以市场需求为导向,致力于国际前沿的靶向新药研究与开发,并力争成为世界领先的靶向新药研发基地,挑战癌症获得性耐药的重大医学难题,使癌症不再是威胁人类生命的头号杀手。

深圳市塔吉瑞生物医药有限公司

行业:
制药.生物
规模:
1-49人
性质:
中外合营(合资/合作)
网址:
http://tjrbiosciences.com/
地址:
广东省深圳市南山 科苑路15号科兴科学园A1-301

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