南平招聘

要求：本科以上学历，做过国内进口注册，具有丰富的项目经验，具有处方药，疫苗或生物制品等注册背景，英语流利交流（无障碍）
 
职责：
1.         Establish, maintain and develop good relationships with China HA, to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
2.         Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and requirements.
3.         Ensure that Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.
4.         Ensure that Import product labeling and PI is consistent with Chinese guidelines and requirements.
5.         Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to China HA.
6.         Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with China HA and requirements.
7.         Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
8.         As required co-ordinate activities with Bio RA.
9.         Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).
 
要求:
1.         Possesses a Bachelor degree in medicine, Biological or medical
2.         Over 5 years regulatory affairs experience, and 2 years experience of assistant manager or manger
3.         Have vaccine regulatory experience is preferred
4.         Strong verbal and written communication skills.
5.         Expert knowledge of regulatory policies and registration processes in China.
6.         Excellent inter-personal skills.
7.         Extensive and close contacts with KOLs and experts.

  Changshu Tonghe Human Resource Service Company (Tonghe Headhunting) is a legally registered and private-owned company with business in Human Resource Consulting & Service area. Established in 2004, with more than 10 years development in Changshu City, now it is a locally well-known headhunting company in Suzhou city. As a local headhunting company, Tonghe Headhunting has successfully supplied good qualified candidates for most of the Foreign Invested Companies in the Yangtze River Delta Area through its professional and practical operation. Due to its efficiency & effective work & consistence in candidates sourcing, Tonghe Headhunting has already set long-term relationship with many well-known multinational companies, such as Novartis of Switzerland, Dowcorning of USA, UPM of Finland, Continental Of German & Danieli of Italy etc. Tonghe Headhunting has been successfully elected as the Vise-Chairman of the Changshu Human Resource Service Association ever since 2011. Within HR circle in Changshu & Yangtze River Delta Area manufacturing fields, Tonghe Headhunting enjoys very good reputation and inflection.
 
  常熟市通和人力资源服务有限公司是经合法登记注册的民营股份制人力资源咨询和服务机构。通和公司成立于2004年初，经过十多年的快速发展，目前已是苏州地区知名的人才猎头公司。 通和公司通过其专业而务实的服务已经成功地为在苏州及长三角地区投资的知名外资企业和大型民营企业提供了众多的优秀人才。 由于在人才招聘方面的高效，准确和持续搜寻能力，通和公司和许多知名外企建立了良好而长期的合作关系。迄今为止，通和公司已经为瑞士诺华制药公司，美国的道康宁公司，芬兰的芬欧汇川纸业，德国的大陆汽车及意大利的达涅利公司等众多知名企业提供了卓有成效的人力资源服务。自2011年起通和公司被评选为常熟市人力资源协会副会长单位。 在当地的人力资源行业及长三角的制造业内通和公司享有良好的声誉和影响力。

Our Mission
    To be a good supplier in HR integrated Service Area.
    To be the friend & consultant for the Professional Talent and High-Level Manager.

我们的使命（ Our Mission ）
    人力资源综合事务的优秀供应商
    高级管理和技术人才职业顾问和益友
  
Our Vision
    Be the influential headhunting company in the manufacturing fields with focus on Chemical & Pharmaceutical & Auto & mechanical.
    Be the well-known human resource supplier in Yangtze River Delta Area in the future.
 
我们的远景（ Our Vision ）
    制造业内知名的专业猎头公司（主要涵盖化工、医药、汽车、机械）
    成为长三角地区知名的人力资源供应商