临床及法规事务
  • 临床及法规事务
  • 药物化学
  • 生物部
  • CMC部
  • DMPK
  • Regulatory Affairs/临床法规

    发布时间:2020年09月24日  


    Senior Manager/Associate Director/Director


    Job Responsibilities

    1 Provide input on regulatory filing strategies for program and study decision making;

    2. Plan and deliver regulatory activities in accordance of program/company goal

    3. Prepare and validate registration dossier for IND, NDA, renewal and variation to ensure timely approval and fully meet authority regulations and guidelines;

    4. Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient way;

    5. Establish internal SOP and WI for regulatory affairs.

     

    Qualifications:

    1. Bachelor degree or above in life sciences, pharmacy, or medicine related majors;

    2. At least 5 years working experience in regulatory affairs for multi-national pharmaceutical companies or CRO

    3. Solid regulatory project management skills

    4.Good leadership and communication skills, ability to interact with different line functions, and to work with outside vendors and partner companies

    5. Good command of English, both in written and spoken.



    立刻申请