Regulatory Affairs

l Compile registration dossier an******** timely regulatory submissionof import drug application or local manufacturing application.
l Keep tracking the project registration process an******** any issuetimely to ensure earliest possible registration.
l Communicate with regulatory agencie******** on product reg********including but not limite******** regulatory ******** review committeemeet******** sample testing.
l Continuously monitor the new regulations an******** of healthcarean******** pro******** an******** the potential impact to projects orcompany business have been thoroughly evaluate******** wellcommunicated.

Qualification:
l Medical/pharmacy/life sciences background, B.S. or above
l Over 2 years regulatory experience in a globe leading pharmaceuticalcompany or CROs
l Familiar with ICH-M4 an********-M8 guidelines，has CTD documentswriting experience.
l Excellent communication skills an******** skills in both Chinesean********
l Goo******** player
l Open att******** Willing to meet challenges
l Indian preferred