Regulatory Affairs Manager
In Vitro Diagnostic Medical Devices
Join the Market Leader
About Our Client
Global In Vitro Diagnostic Medical Devices Company, leading in Asia-Pacific region and Japan.
・ Strategic communication with PMDA / MHLW / MAFF
・ Support for planning / execution of clinical trial plans in Japan and overseas (including GCP)
・ Data analysis, summary and CSR creation
・ Communication with pharmaceutical companies, academia, KOLs, etc.
・ Communication with Global RACC
・ Preparation of regulatory approval application materials, inquiries until approval / subcommittees, etc. PMDA / MHLW / MAFF
Responding to requirements
・ Supports GCP / reliability survey
The Successful Applicant
・ Experience in clinical development / regulatory approval application / reliability assurance work
・ Experience in planning / managing clinical trials or clinical trials, and creating protocols based on regulatory affairs strategies
・ IRB support experience in clinical trial facilities, clinical trial contract experience
・ Has knowledge of related laws and regulations (Pharmaceutical Machinery Law, ISO13485, GCP, Clinical Research Law, etc.)
・ Knowledge in molecular biology / gene analysis / oncology area
What's on Offer
Development of a growing business unit directly under APAC. Career opportunities on a truly global scale.