Responsibility:

• Follow up governance principles. Provide and update products registration strategy and plan for PH and CC according to regulation.
  
• Provide consultation result of relative products and give the correct suggestion to Sr. RA manager and relative departments of BHC.
  
• Registering and renewing all licenses and other special approval on time.
  
• Quality control the registration application and dossier, follow up the evaluation procedure, solve problem in registration.
  
• Change management in RA: Update and file product information includes production information, quality control information, shelf life, and information in package materials in accord with information from Headquarter for responsible products. Archive relative product's document according to SOP.
  
• Project management for NCE drug registration: book dossier from HQ, coordinate dossier preparation of CMC, Pre-clinical, and clinical parts.
  
• Influence to Chinese authority. Establish the relationship and friendship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
  
• Coaching registration officer, help registration officer to solve problems. Manage the department when manager is not on duty.

Requirement:

• Bachelor degree or above on chemistry, pharmacy, pharmacology, medicine
  
• More than 8 years working experience in pharmaceutical industry or institute, and 2-3 years registration experience, registration experience of oncology is preferred
  
• Professional knowledge on Chemistry, Pharmacy, Pharmacology, and clinical trial.
  
• Well know professional knowledge on regulatory affairs regulation: Chinese regulations, international guideline (ICH, FDA, EMEA)
  
• Well know Bayer related SOP
  
• Fluent business Chinese writing skill for Authorities
  
• Good negotiation skill
  
• Good communication skill
  
• Good team spirit
  
• Good at English
  
• Solid computer skill on Word, Excel, PowerPoint, internet, intranet, lotus notes Microsoft project and self-learning.