Job Responsibilities:

• Follow up governance principles. Provide and update products registration strategy and plan for PH according to regulation.

• Provide consultation result of relative products and give the correct suggestion to TA 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.

• 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

Requirements:

• Bachelor degree or above on chemistry, pharmacy, pharmacology, medicine

• At least 1 year registration experience.

• Professional knowledge on Chemistry, Pharmacy, Pharmacology, and clinical trial.

• Well know professional knowledge on regulatory affairs regulation: Chinese regulations, international guideline (ICH, FDA, EMEA)

• 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.