Regulatory Officer
Core
Facilitate the start of research projects for novel medicinal products by managing regulatory and ethics committee submissions in China.
Role type
Regulatory Officer (Clinical Trials)
Builds
Regulatory and ethics committee submission dossiers, import/export license applications
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical trial submission management, regulatory document preparation, translation review, legislative tracking, database maintenance
Preferred skills
Project documentation flow tracking, amendment monitoring
Technologies
MS Office
Responsibilities
Liaise with project teams to procure documents for submissions, prepare submission dossiers, review translations of essential documents, track regulatory documentation flow, monitor legislative changes in PSI countries, maintain regulatory requirements database
Seniority
Mid-level, individual contributor
