Senior Regulatory Officer
Core
Facilitate the start of research projects for novel medicinal products by preparing and overseeing clinical trial submissions and managing regulatory processes.
Role type
Senior Regulatory Officer (Clinical Trials)
Builds
Clinical trial submissions and regulatory documentation for novel medicinal products
Domain
Healthcare / Clinical Research / Regulatory Affairs
Required skills
Clinical trial submission strategy, CTIS system expertise, regulatory risk identification, safety reporting, document review, translation review, regulatory training delivery
Preferred skills
Experience in Slovakia, feasibility research, business development requests
Technologies
CTIS, MS Office
Responsibilities
Coordinate CTIS submission, discuss submission strategy with sponsors, identify regulatory risks and mitigation plans, manage consistency of regulatory processes across trials, communicate with authorities and ethics committees, review translations of essential documents, track regulatory documentation flow, review documents for IP release, manage safety reporting, deliver regulatory training
Seniority
Senior, hands-on IC
