For Our Client | Regulatory Affairs Manager – Drug Registration Jobs

German Industry & Commerce Guangzhou Branch, Beijing, China

About Company:

Our Client is a manufacturer of pharmaceutical-grade amino acids and related APIs, intermediates and/or exicpients with headquarter in Frellstedt, Germany.

Our Client wishes to expand its sales territory to service the global and domestic pharmaceutical industry and hence intends to set up a representative office in Beijing.

At this position, you will be the first employee of our Client in China and has the opportunity to become the Managing Director of their Chinese subsidiary.

About this job:
  • Interaction with suppliers, customers and (Chinese) authorities
  • Compilation, maintenance and submission of drug master files & registration dossiers
  • Monitoring of relevant laws and directives (with respect to API and/or excipients registration)
  • Internal and external contact for regulatory affairs related topics
Requirement:
  • University or college degree in life sciences and/or comparable training
  • At least 5 years’ experience in RA , with focus on drug registration is preferred.
  • Initial experience of regulatory affairs and interaction the Chinese authorities
  • Reasonable knowledge of cGMP rules and standards
  • Assertiveness and negotiation skills
  • Verbal and written command of the English language
  • Willingness to travel
Native Language: Chinese
Working Experience: above 5 years
How to apply:

If you are interested in this position, please kindly send your English CV with salary expecation to Ms. He by he.ashley@gz.china.ahk.de

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