Bratislava-Ružinov, Bratislava, Slovakia
Regulatory Affairs & Clinical Trial Start-Up professional with extensive experience across CRO, sponsor, Pharma, and MedTech environments. Specialized in EU CTR (536/2014), CTIS, Clinical Trial Applications (CTA), regulatory start-up, lifecycle management, and multi-country submissions across Europe and global programs. Proven track record supporting interventional, non-interventional, and medical device studies with strong focus on compliance, inspection readiness, risk management, and on-time milestone delivery. Currently expanding expertise in Medical Device Regulation (EU MDR 2017/745) and Quality Management Systems (ISO 13485), strengthening capabilities across pharmaceutical and MedTech regulatory frameworks. Core Expertise: • EU CTR / CTIS • CTA & Regulatory Submissions • Clinical Trial Start-Up (SSU / RSU) • Regulatory Lifecycle Management • EU MDR / Medical Devices • ISO 13485 / QMS • eTMF / Veeva Vault / Regulatory Systems • Cross-Functional Stakeholder Leadership • Inspection Readiness & Documentation Compliance EU citizen (no sponsorship required) | Open to EU / CH / Remote opportunities Website: ioannispap.com
Regulatory lead for CTA/CTIS submissions, documentation readiness, and cross-functional activation for interventional, non-interventional, and medical device studies across US, Brazil, South Korea, and EU regions. Professional Recognition: SPARK Award – Partnership Excellence, AstraZeneca (2025) Formal recognition for professionalism, dedication, and outstanding collaboration on AstraZeneca-sponsored clinical studies. - Directed regulatory strategy for site activation, ensuring compliant submissions across multi-country studies and alignment with authority requirements (Swissmedic, EMA, FDA). - Accelerated regulatory start-up timelines by 30% via optimized CTIS workflows and proactive engagement with RA and Clinical Operations. - Managed preparation and delivery of CTA documentation packages and multi-country amendment submissions. - Led cross-functional collaboration to ensure audit-ready documentation and adherence to regulatory deadlines. - Reduced time-to-activation by 15% through improved sponsor communication and streamlined documentation readiness. - Oversaw regulatory deliverables across 13 countries for a single study; supported four studies concurrently. - Delivered submission packages under 6-week deadlines, avoiding financial penalties for the sponsor. - Key achievements: Delivered multi-country submissions in 6-week windows | Improved CTIS efficiency by 30%.
Supported regulatory submissions, country-level authority interactions, and documentation readiness across multiple EU regions. - Coordinated regulatory document preparation and submission workflows for Belgium, Germany, and additional EU countries. - Oversaw SSU lifecycle with emphasis on EC/RA communication, compliant submissions, and country-specific requirements. - Managed multi-country regulatory timelines across 12 regions, ensuring sponsor visibility and compliance. - Supported document packages for submissions to Swissmedic and other competent authorities. - Maintained full audit alignment resulting in zero audit findings.
- Oversaw startup planning and sponsor-specific submission requirements (Janssen). - Coordinated regulatory deliverables (LEC/CEC/RA) and maintained authority submission tracking. - Ensured documentation compliance and updated sponsors on regulatory progress.
- Managed startup submissions and regulatory authority interactions in Austria, Germany, and Greece. - Prepared CTA submission packs and coordinated country adaptation reviews. - Acted as ICF lead, ensuring compliance with local ICH-GCP and national regulatory requirements. - Supported contract and budget negotiations aligned with local regulatory processes.
- Served as SPOC for ICF and regulatory documentation adaptation across USA, Canada, and EU regions. - Supported Swissmedic regulatory alignment and documentation preparation for Swiss submissions.