Regulatory Affairs Manager

Responsibilities
-Familiar with CFDA, FDA relevant regulat******** standards an********.-Understan******** regulatory pathway of the responsible productsan******** the appropriate regulatory pathway
-Oversees CRO an******** registration dossier an******** timelyregulatory submission.
-Keep tracking the project registration process an******** any issuetimely to ensure earliest possible registration
-Communicate with regulatory agencie******** on product reg********including but not limite******** regulatory ******** review committeemeet******** sample testing
-Buil******** an******** a reliable an******** relationship withregulatory authorities (e.g., CFDA, CDE, Provincial FDAs) an******** keyplayers in the regulatory environment
-Provide regulatory expertise to the R&D projects includingbiologics an******** molecular drug products
-Continuously monitor the development of regulations an******** ofhealthcare an******** pro******** an******** the potential impact toclinical projects have been thoroughly evaluate******** wellcommunicated.

Qualifications
-BSc or Master’s Degree in chem******** pharmacy or related, or MD(license******** the country, if appl******** according to localregulations)
-Min 5 years experience in pharmaceutical industry or relate********like medical devices or healthcare industry
-Goo******** of written an******** English
-Goo******** of the Chinese an******** regulations
-Competent project management skills
-Ability to handle multi-task activities
-Ability to handle conflict; initiative an******** skills