Vitali Boroch

• Responsibility for quality management system maintenance and development (ISO 9001), including documentation, process updates and internal audits. • Data protection officer function: implementation and monitoring of GDPR-compliant processes. • Management of pharmacy operations: staff coordination, training and supervision. • Handling of regulatory and reimbursement-related inquiries in a GxP-adjacent environment.

On-site family support and care coordination in Ukraine.

Regulatory Affairs Associate with experience in lifecycle management and labeling for the German market: SmPC, PIL, packaging/artwork, EMA/BfArM requirements, Type IA/IB/II variations, product launches incl. BfArM submissions and Lauer-Taxe listing, DHPC/RMM/Rote Liste, clinical study support for Yescarta/Tecartus, HWG review of medical/promotional materials, and GDP, supply-shortage and audit preparation incl. risk matrix.

Additional to typical tasks of a retail pharmacist: • Medication therapy management; • Data protection management; • Support in the quality management system; • Supervision of pharmaceutical interns.

Six-months internship with main tasks: • Qualification of medical device suppliers; • Risk analysis of combination products; • Support in the management of registration dossiers; • Complaint investigation of medication, packaging and medical devices used in global studies.