Regulatory Officer
Core
Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, manage safety reporting, and facilitate the start of research projects for novel medicinal products.
Role type
Regulatory Officer (Clinical Trials)
Builds
Regulatory submission dossiers and safety reports for clinical studies
Domain
Healthcare / Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical trial submission preparation, Regulatory authority communication, Ethics committee liaison, Document translation review, Safety reporting management, Regulatory training delivery, Feasibility research support
Preferred skills
Import/Export license application handling, Project documentation tracking, IP release review
Technologies
MS Office
Responsibilities
Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, Communicate with regulatory authorities and project teams, Review translations of essential documents, Track regulatory project documentation flow, Manage safety reporting to authorities, Deliver regulatory training to project teams
Seniority
Individual Contributor, Mid-level
