Edyta Maciolek

Regulatory Affairs Manager

CTR Consulting, Poland

A clinical trials professional with over 15 years of experience in the pharmaceutical and biotechnology industry. Throughout career holding different positions in Clinical Operations, Project Management and Regulatory Affairs. Accountable for operational and strategic aspects of regulatory services for the assigned projects, in the role of Regulatory Affairs Manager performing and overseeing European submissions.

Well-established knowledge of ICH-GCP guidelines and European Union regulations on clinical trials, as well as good understanding of local regulatory requirements in countries across the Europe. Extensive therapeutic and country experience.

SPOR Industry and CTIS super user. Certified user of xEVMPD and responsible person (RP) for EudraVigilance. Subject Matter Expert for Regulatory Affairs and clinical trials in Europe.
Registered member of TOPRA, The Organisation for Professionals in Regulatory Affairs, member of Drug Information Association (DIA) and Polish Association for Good Clinical Practice (GCPpl).
Owner of CTR Consulting serving as independent (freelance) consultant for EU CTR and CTIS.