Location Beijing, China Date Posted July 15, 2014 Specialism Pharmaceutical & Medical

Role Profile

Role Description

  1. Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
  2. Manage regulatory project efficiently and independently.
  3. Lead working group to attain to target goals
  4. Perform gap analysis on SFDA requirement and propose solutions;
  5. Provide technical suggestion or help to other RAS as internal expert in some field
  6. Besides product submission, take responsible for RA internal program and projects
  7. Have a sound understanding of, and comply with, the Code of Conduct and Company Compliance requirements.

Person Description

  1. Bachelor’s degree or above in related scientific discipline; Medical, pharmaceutical, material science and engineering background is preferred
  2. With a minimum of 5 years regulatory experience as RA function in medical device industry
  3. Sound basis of Regulatory knowledge and Scientific Knowledge.
  4. Team management skill for small working group
  5. Skill to coach junior RA staff and help them to grow up
  6. Good communication skill and team work
  7. Strong oral and written communication in English and Chinese
  8. Ability to independently identify compliance risks and escalate when necessary;
  9. Good skill on Word, Excel and Powerpoint.

 

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