Location | Beijing, China | Date Posted | July 15, 2014 | Specialism |
Pharmaceutical & Medical
|
Role Profile
Role Description
- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
- Manage regulatory project efficiently and independently.
- Lead working group to attain to target goals
- Perform gap analysis on SFDA requirement and propose solutions;
- Provide technical suggestion or help to other RAS as internal expert in some field
- Besides product submission, take responsible for RA internal program and projects
- Have a sound understanding of, and comply with, the Code of Conduct and Company Compliance requirements.
Person Description
- Bachelor’s degree or above in related scientific discipline; Medical, pharmaceutical, material science and engineering background is preferred
- With a minimum of 5 years regulatory experience as RA function in medical device industry
- Sound basis of Regulatory knowledge and Scientific Knowledge.
- Team management skill for small working group
- Skill to coach junior RA staff and help them to grow up
- Good communication skill and team work
- Strong oral and written communication in English and Chinese
- Ability to independently identify compliance risks and escalate when necessary;
- Good skill on Word, Excel and Powerpoint.
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