Job Description Summary
Responsible for Imported BDI_PI Products Regulatory Affairs
Job Description
KEY RESPONSIBILITIES (主要职责)
- Maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues.
- Make charge of new products launch in China, including make strategy, control registration timeline, type test, prepare registration documents, following evaluation and get approval.
- Host regular meeting with WW to get requested documents and update registration status.
- Follow NMPA regulations and analysis impacts to BD or responsible products. Other affairs within the team.
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SKILLS AND ABILITIES (技能)
- Medical/Pharmacy background, relevant experience on regulatory affairs
- Bachelor degree or above
- At least 2 years of regulatory affairs experience
- Proficient in spoken and written English and Chinese
- Ability to work independently and experience in a team on multiple projects Excellent interpersonal and communication skills
DESIRABLE (优先条件)
- Medical device company working experience
- Overseas education background
Required Skills
Optional Skills
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Primary Work Location
CHN Beijing
Additional Locations
Work Shift