Regulatory Officer
Core
Facilitate the start of research projects for novel medicinal products by managing regulatory submissions and coordinating with authorities and project teams.
Role type
Regulatory Officer (Clinical Trials)
Builds
CTR Part II submission packages for Italy
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
CTR Part II submission expertise, regulatory document review, translation review, regulatory documentation tracking, IP release coordination
Preferred skills
Scientific University degree, MS Office proficiency, dynamic team collaboration
Technologies
MS Office
Responsibilities
Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR), Prepare and coordinate CTR Part II submission packages for Italy, Communicate with regulatory authorities, project teams and vendors on regulatory-related matters, Review translations of essential documents subject to clinical trial submission, Track the regulatory project documentation flow, Review documents to greenlight IP release to sites
