北京招聘

This position is provied by Fresenius-kabi Pharmaceutical (Wuhan) co., LTD -Plant

Job Description:

Regulatory Affairs
1. Documentation of development as well as manufacturing processes
2. Establishment of the CMC part of the regulatory dossier for submission in PRC
3. Compilation of complete Regulatory Documentation (in the companies document management system KIPDIPS) suitable for obtaining marketing authorisations in PRC.
4. Knowledge in working in an international environment, i.e. using global document management systems and regulatory status tracking software, i.e. RegTrack)
5. Liaison with Regulatory Affairs teams within the global development network
6. Excellent command of English language and ability to travel outside the PRC. Proven experience in managing international work relationships.
7. Project management, i.e. documenting and controlling project progress vs project planning utilizing FKs Global Project Management methodology.


This position will require a set of experiences which can only be obtained after 3-5 years in industry. The candidates will have a background of chemistry, chemical technology or pharmacy and should have had already exposure to an international environment.

北京费森尤斯卡比医药有限公司（以下简称北费）是德国费森尤斯卡比股份公司在中国的全资子公司，成立于1994年，致力于将费森尤斯卡比集团的优质药品、先进技术以及治疗理念引进中国。目前。北费在中国生产和销售的主要产品系列包括：代血浆--万汶、贺斯；延缓肾衰药物--开同；静脉麻醉剂--静安、竟安；以及17种、18种氨基酸常规输液等。除国内生产销售外，北费生产的开同还出口全球多个国家。