湖州招聘

1. Develop a best-in–class CMC registration team to meet the current and future business needs in China. 

2. Provide leadership in the development of CMC registration strategies for CMC projects. Effectively manage all CMC registration projects in ** portfolio. 

3. Effectively communicateto all key stakeholders to ensure all scientific and regulatory CMC issues are well consulted/communicated with CFDA/CDE/NIFDC and clearly communicated with GRA and local teams;

4. Establish and maintain a good relationship with key CMC regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc via professional communication.

5. Provide high standard of the CMC submission documents with a first-time-right approach to minimize the CDE review timeline and to ensure the agreed CMC registration timelines are delivered.

6. Provide support and coach to regulatory CMC colleagues in the team to solve the CMC problems occurred during CMC project registration to achieve CMC projects registration approvals in a timely and effective manner.

7. Provide strategic and technical regulatory CMC input and support to Head of Regulatory Affairs for the capability development, improvement and management of the regulatory organization.

8. Make sure to generate competitive PIs CMC part which comply with CFDA and ******** requirements.

9. Ensure the maintenance for all registered CMC projects.

10. Oversight budget and implementation in accurately and timely manner for CMC projects.

11. Provide timely and high-quality regulatory CMC support and input to internal key stakeholders such as medical, commercial and GMS site as needed.

12. Establish and maintaining inter/intra departmental processes and channels of communication.

1.Master or Ph.Ddegree in life science (pharmacy, chemistry, biology or related background) plus 10 years regulatory affairs working experience and over 5 years leadership role experience in MNC Company.

2.Proven ability to communicate (written/oral) in English

3.Ability to build, maintain and lead an efficient and well-motivated team

4.Good verbal and written communication skills

5.Ability to present clearly and effectively to a variety of audiences inside and outside

6.Good leadership and people-management skills

7.Ability to handle with emergency things and provide quick response

  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