Responsibility:
1.Responsible?for?new?product?registration,?product?license?renewal,?registration?changes?and?trial?application,?including?prepare?registration?dossiers?correctly?and?timely.
2.Have?a?good?understanding?of?Chinese?regulatory?environment.
3.Implement?regulatory?activities?as?required?by?governmental?regulations?and?internal?SOPs.
4.Follow?up?the?registration?process,?and?communicate?with?SFDA,?CDE?and?other?governments?or?departments?effectively.
5.Participate?in?all?required?internal?and?external?trainings.
?
Requirements:
1.Bachelor?or?above?degree?in?pharmacy?or?similar?field.
2.?Drug?registration?experience?is?a?plus.
3.Good?understanding?of?local?regulations,?guidelines?and?requirements?and?have?experience?in?preparation?of?submissions.
4.Good?English?skills?both?in?written?and?oral.
5.Proficiency?in?Excel?and?other?MS?office?tools.
6.Good?communication?skills?with?cooperators?and?colleagues.