Regulatory Affairs Specialist

release time:2018-09-04    view:5364

Recruitment number: 2

Education:Above 5 years of work experience in regulatory affair in ANDA submission. Be familiar with regulation of FDA EU WHO and ICH. Have good ability in communication and relationship maintenance.


Master in pharmacy and related discipline.

Responsible for the dossier submission, maintenance and follow-up in the regulatory market, Coordinate internal and external resource. Make sure the registration document meet the requirement of SOP and FDA regulation. Update the latest international regulation to support company strategic decision.