PROFESSIONAL SUMMARY Seasoned Regulatory Affairs & Quality professional with 20+ years of experience in the pharmaceutical industry, specializing in Regulatory Operations at local, regional and global level, Artwork & Packaging Compliance, QMS adherence, and cross‑regional regulatory support. Recognized Subject‑Matter Expert (SME) in end‑to‑end artwork processes, Deviation Management, RCA/CAPA using DMAIC, Regulatory change implementation, data integrity (ALCOA principles) and audit readiness and management monitoring. Track record of leading complex cross‑functional program, delivering global system deployments, optimizing Shared Pack strategies, and driving automation and digital transformation across Regulatory and Artwork functions. Strong leadership, strategic thinking, and consistent delivery of inspection-ready processes. CORE COMPETENCIES - - Global / local Regulatory Operations for EEU, CIS, international countries: preparation of the registration dossier in accordance with regulatory requirements, incl. ND, leaflet (PIL&HCP), artworks, consumer testing, communications with Health Authority and Central office, response to questions, variations. - Knowledge in local regulation, readiness to analysis local regulation. - Artwork & Packaging Compliance (E2E) and knowledge in packaging regulation across a world. - Process Design, Optimization & Standardization, Digital Transformation & Automation (ePIL, digital proofreading, AI-driven workflows) - Cross-functional Collaboration (Quality, RA, Supply Chain, Manufacturing), Stakeholder Engagement & Training - QMS, Lean Six Sigma - Deviation Management, RCA & CAPA (DMAIC‑certified) - Audit & Inspection Support (GMP/IBM), Management Monitoring, Documentation Governance (SOP), Risk management, Change management and control, KPI, data integrity (ALCOA principles). - Shared Pack Strategy & Portfolio Optimization PROFESSIONAL EXPERIENCE 12/2018 – 02/2026 GlaxoSmithKline (GSK) – Emerging Markets Regulatory Strategy Regional Shared Pack & Artwork Manager, Emerging Markets (LATAM, MENA, CIS, Russia, Africa, India, Pakistan, Asia) - Regulatory Operations & Artwork Governance - Artwork creation for multiple markets in different languages in accordance with local requirements via AW management system (GLAMS), incl. leaflets for consumer testing. - Implementation of Serialisation, ePIL, Braille for different markets incl. Russia and CIS. - Primary RA contact for Quality, Artwork, Regulatory and Supply Chain ensuring compliant E2E pack implementation. - Sole Regulatory Artwork support across all regions outside US & Europe, ensuring Regulatory and QMS‑compliant artwork delivery. - Planning Global projects (Product transfer, pack optimization and other) based on local / packaging regulation. - Shared Pack Strategy, enabling new launches and improving portfolio efficiency. Regulatory Quality Compliance Responsibilities - QMS implementation in Regulatory function. - Acted as SME during GMP/IBM audits, supporting inspection readiness including investigation and CAPA for audit findings. - Preparation, implementation and analysis of results of management monitoring. - Leadership of deviations, ensuring timely, compliant investigation with DMAIC methodology, robust RCA, and effective definition, implementation, and verification of CAPAs as CAPA Owner in line with QMS requirements. - Ensured adherence to internal Quality Systems, including global artwork monitoring and deviation governance. - KPI definition and design - Define meaningful, measurable, and risk‑based KPIs for Artwork & Labelling processes aligned with Quality and Regulatory priorities. Ensure KPIs have clear purpose, scope, targets, thresholds, and escalation criteria in line with QMS expectations. - Drive development and revision SOP, Working Instruction, creation of How to Guide. - Change Control and Risk Management. Digital Transformation & Automation - Introduced digital proofreading/spelling check, eliminating manual comparison and reducing risk of regulatory errors. - Drove development of AI‑driven artwork change initiation, linked with RA and Artwork systems. - Digitalized AW checklist (e‑signatures, compliant storage). Leadership - Established and led a global Artwork Collaboration Platform across Regulatory.

Regulatory Implementation Lead for a new AW Management system (Harmony) across all Regulatory regions incl. Global Regulatory. - Led global deployment of a new Regulatory Artwork Management System across all RA regions. - Directed global regulatory readiness, governance, and cross‑functional integration. - Owned system design, process mapping, and global change management strategy. - Developed regulatory market requirements, documentation, training, and SOP contributions.

- Oversee Shared Pack strategy and Artwork operations for MENA‑CIS region. - Strengthen QMS alignment and cross‑functional process compliance. - Drive continuous improvement and artwork delivery reliability for multi‑market operations.

Leading AW management process for Russia incl. all supportive activities – cross-functional interaction, tasks, systems.