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Regulatory Affairs Supervisor

更新日期:2020-02-28
工作經(jīng)驗(yàn):
無要求
最低學(xué)歷:
本科
招聘人數(shù):
1
語言要求:
工作性質(zhì):
薪資范圍:
1-1.2萬/月
職位類別:
工作地點(diǎn):
廣州市
分享到:
職位描述公司簡介

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.


Lonza Guangzhou Nansha Ltd was established in April 2003, expanding Lonza’s global presence for chemical manufacturing and life science ingredients.


Regulatory Affairs Supervisor will execute the Chinese and international drug registration according to the business needs, assist Nansha and other sites by providing local and regional regulatory consultation services and keep effective communication with Health Authorities and customers on regulatory affairs.

  

Key responsibilities:

  

  • To coordinate worldwide product registration activities for Nansha and its customers.

  • To provide consultation services and regulatory solutions to assist quality management and manufacturing operation in Nansha.

  • To maintain product licenses, establishment registration, DMF, PMF, etc for Nansha.

  • Collect and analysis local and regional regulatory information, and conduct regulatory training to internal staffs.

  • To establish/ maintain communication channels with health authorities.

  • GMP Responsibility:

            

  • To assess Change Requests for regulatory impact.

  • To maintain SMF and site licenses, e.g. Drug Manufacturing License, Written Confirmation etc.

    

  • Perform other duties as assigned.

    

Key requirements:

  

  • Bachelor degree or above majoring in Pharmacy and chemistry or relevant major.

  • Significant experience in drug registration.

  • Fluent in Chinese and English.

  • Good communication with good rational & logics , and be careful, positive and responsible.

        


Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.


People come to for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

聯(lián)系方式:

公司網(wǎng)址:http://www.lonza.com.cn
公司地址:廣州市海珠區(qū)金輝路39號
聯(lián)系電話:34973888-2590

龍沙(中國)投資有限公司成立于2003年9月,是瑞士龍沙集團(tuán)全資在廣州設(shè)立的投資性公司。公司旨在于醫(yī)藥、化工及生命科學(xué)領(lǐng)域進(jìn)行投資和再投資,同時提供以下服務(wù):

-協(xié)助或代理龍沙所投資企業(yè)的貨物及設(shè)備采購業(yè)務(wù),并在國內(nèi)外市場銷售他們的產(chǎn)品;

-為龍沙所投資企業(yè)提供售后服務(wù)、技術(shù)支持及人力資源服務(wù);


-為投資者提供咨詢服務(wù)并為龍沙的關(guān)聯(lián)公司提供市場信息、投資政策等咨詢服務(wù)。


龍沙(中國)投資有限公司

  • 企業(yè)性質(zhì): 三資企業(yè)
  • 業(yè)務(wù)范圍: ITO,KPO
  • 所屬行業(yè):醫(yī)藥/生物工程
  • 公司地址:廣州市海珠區(qū)金輝路39號

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