職位描述
職位描述：
Major Accountabilities
·Responsible for supporting regulatory submission for all new products and life cycle management of marketed products in China, aligned with Regional regulatory and Area business strategies and plans for VC business.
·Support the consolidation of regulatory filings to ensure we are fully compliance.
·Maintain the Insight and D2 systems and any other regulatory systems.
·Update and Maintain China Regulatory Affairs Sharepoint site.
·Track the RIAR activities in China.
·Support any regulatory affairs administrative activities.
Ideal Background
Education / General
University degree or equivalent in biomedical field and higher degree with no experience in Regulatory Affairs required. Good command in English for both oral and written.
Expertise/Experience/Skills
?Some knowledge of the regulations affecting the Pharmaceutical and medical device industry in Area; including both pre-market and post-approval regulations. A working knowledge of regulatory review and approval processes in other global markets
?Action oriented with proven ability to move projects through to approval and commercial success.
?High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.
?Transparent communicator..
企業(yè)簡介
愛爾康（中國）眼科產(chǎn)品有限公司，英文名Alcon (China) Ophthalmic Product Co., LTD, 是美國愛爾康公司在中國設(shè)立的獨(dú)資公司。美國愛爾康公司是全球最大的眼科產(chǎn)品公司，自一九四七年成立以來一直致力于眼科產(chǎn)品領(lǐng)域的研發(fā)、制造及銷售，目前在眼科用藥、眼科手術(shù)用品及儀器、隱形眼鏡護(hù)理液三大產(chǎn)品領(lǐng)域均居全球領(lǐng)先地位。
一九七八年愛爾康公司加入雀巢集團(tuán)，并于2002年在美國紐約掛牌上市，目前在全球70多個(gè)國家設(shè)有分公司，超過170個(gè)分支機(jī)構(gòu)，擁有員工14,500人，全球并設(shè)有5個(gè)研發(fā)中心、14個(gè)制造工廠及40個(gè)專業(yè)培訓(xùn)中心。愛爾康公司已經(jīng)連續(xù)十年被財(cái)富雜志評為全美“100家最佳雇主”之一。
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