高級注冊專員SeniorRegulatoryAffairsSpecialist

Key?Job?Responsibilities:
·?Provide?regulatory?consultation?for?in-house?clinical?projects?or?stand-alone?regulatory?projects
·?Compile?and?submit?INDs/CTAs?and?NDAs/MAAsConduct?QC?reviews?of?regulatory?documents,?such?as?Investigators’?Brochure
·?Remain?current?with?changing?regulatory?requirementsResponsible?for?post?marketing?registration,?new?product?registration,?product?license?renewal,?registration?changes?and?trial?application,?including?prepare?registration?dossiers?correctly?and?timely.
·?Have?a?good?understanding?of?Chinese?regulatory?environment.
·?Implement?regulatory?activities?as?required?by?governmental?regulations?and?internal?SOPs.
·?Follow?up?the?registration?process,?and?communicate?with?SFDA,?CDE?and?other?governments?or?departments?effectively.
Job?Qualifications:
·?Bachelor?or?above?degree,?preferably?in?life?science?or?related?course
·?5?year?drug?registration?experience?in?pharmaceutical?industry
·?Good?understanding?of?local?regulations,?guidelines?and?requirements?and?have?experience?in?preparation?of?submissions.
·?Good?English?skills?both?in?written?and?oral.
·?Proficiency?in?Excel?and?other?MS?office?tools.
·?Good?communication?skills?with?cooperators?and?colleagues.