Position: Specialist of Regulatory Affairs
Location: Beijing/Shanghai, China
Report to: Manager of Regulatory Affairs
Key Responsibilitie********
Compile registration dossier an******** timely regulatory submissionof import drug application or local manufacturing application.
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.
Continuously monitor the new regulations an******** of healthcarean******** pro******** an******** the potential impact to projects orcompany business have been thoroughly evaluate******** wellcommunicated.
Qualification:
Medical/pharmacy/life sciences background, B.S. or above
Over 2 years regulatory experience in a globe leading pharmaceuticalcompany or CROs
Be familiar with regulations an******** in CFDA, FDA an********
Excellent communication skills an******** skills in both Chinesean********
Goo******** player
Open att******** Willing to meet challenges
Qualifie******** are welcome******** sen******** CV to ******** .