
注冊專員

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工作è·è²¬(zé):
-Assist Regulatory Affairs Manager for the applications for New Drug Products, variations of marketed products and license renewals within the set timeframe and conducting in compliance with local regulatory agency requirements as well as relevant Pfizer SOP
-In the relevant therapeutic area, provide relevant regulatory supports to the Medical groups and to other company personnel
-Follow up submission, QC testing, evaluation and approval in SFDA, CDE and official labs
-Keep effective and close communication with HQ and other internal function teams
-Closely monitor new regulations and evaluate the impact to company
-Develop and improve good relationship with the authorities and KOLs
-Follow and implement internal SOP for routine work
-Report to line management regularly
ä»»è·è³‡æ ¼ï¼š
-Bachelor degree or above in pharmaceuticals, chemistry, biological and related major
-At least 6 months working or intern experience in drug product registrations working at a high level of competency
-Good communication skill in both English and Chinese
-Good project management and problem solving skill with team work spirit
-Self-motivated and willing to work under pressure
-Good Computer skill
-Good communication and team cooperation skill
-Registration project management skill, effective problem solving, organizing and planning capabilities
-Essential knowledge on international and Chinese regulations as well as technical guidance
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伿¥(yè)è¦(guÄ«)模:5000-10000人
æˆç«‹å¹´ä»½ï¼š1989
伿¥(yè)ç¶²(wÇŽng)å€ï¼šwww.pfizer.com.cn
伿¥(yè)地å€ï¼šbeijing