jobapplier

Regulatory Officer

PSI CRO

This job is closed: the employer no longer lists it.

Responsibilities

  • Hybrid working arrangement in Milan area Your role: 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