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