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医药 / 医疗器械 / 生命科学行业
Registration officer
Major Responsibilities:
- Assist for preparation, submission and follow-up for new drug registration application, including ordering dossiers from HQ, Preparing submitting dossiers, following up and solving problems
- Coordinate dossier preparation of CMC, Pre-clinical, and clinical parts, including arranging translation and checking
- Responsible for maintaining licenses, covering license renewal, LRL applications and supplementary applications
- Coordinate for the lab test for some applications, solve problems and ensure the lab test completed timely and properly
- Build and maintain good relationships with officials and experts of relative authorities; good communication with officials and experts to guarantee smooth registration
- Follow up closely with the information of relevant competition products
- Collect periodically new relevant laws and regulations from SFDA and CDE website and provide comments
- Provide consulting result of relative products and give the correct suggestion to TA manager and relative departments of BHC
- Help to do the archiving work within the team
Requirement:
- Bachelor degree or above on chemistry, pharmacy, pharmacology, medicine
- At least 1-year Regulatory Affairs related experience preferred.
- Professional knowledge on Chemistry, Pharmacy, Pharmacology, and clinical trial.
- Be familiar with corresponding regulations and procedures: SFDA regulations and international guideline (ICH, FDA, EMEA)
- Chinese writing ability for formal letters
- Good negotiation skill
- Good communication skill
- Good teamwork
- Good at written and oral English
- Solid computer skill
若您有意此职位,请发送个人简历到 resume@impresschina.com
If you are interested in this position, please send resume to resume@impresschina.com