Olena Saulina

May 2022 – May 2024 • Frontend support of Labelling Process (New Global Labeling SOP Implemented since 14.06.2022) • E2E process enhancement: consistency check of data in Labelling tools, training in the labeling literacy • Secretary of Core Label Management Board (compliance board which endorses any kind of changes for core products ) • Support and maintenance of Label Deviation Process

• New Team Build up • Transparent and effective cross functional communication with internal stakeholders • GMP inspections, offline & online formats • Marketing Autorisation Approvals • Maintenance of regulatory post marketing procedures

• Strategic planning on regulatory procedures in the foreign markets (LATAM, GULF & ASIA) • Effective cooperation with internal and external business partners per regulatory procedures completion (clarity and transperancy in local regulatory requirements, docs preparation & release, timely submissions) • Search of new regulatory partners • Effective interaction with Competent Authorities • Lobbying the company's interests within my competencies • Regulatory risk assessment of ongoing regulatory procedures

• Implementation of effective communication within the team • Development and implemention of a regulatory strategy for the assigned projects • Regulatory Risk Mitigation • Optimization of internal business process (sampling, safety labeling & PV process implementation in Africa region) • Assistance in Multi-Country (Regions) Regulatory Strategy development, implementation • Product recalls in the assigned regions • Resource and Process management across multiply teams to manage timely regulatory submis

PRODUCTS PORTFOLIO • Regulatory support and maintenance of the full life cycle of the products • Tracking systems support • ACO (Addendum to the Clinical Overview) preparation • Effective cross functional communication with internal and external stakeholders on a sound dossier preparation by following the local regulatory guidlines (CMC department, Medical Department, Global RA, LEAD) • Mocksups and Artworks development and approval in AMS database Regulatory Document Archiving

• Maintenance of regulatory procedures (registration & changes) • Compilation of regulatory dossiers and PIL following Ukrainian regulatory Guidelines • Communication with internal business partners (Deficiency Letters, Quality Requests) • Maintenance and Management of GMP recognition of the manufacturer communication. • Third party cooperation in packaging development and approval following local regulatory guidelines • Translation

• Search of cell culture worlwide • Communication with internal and external business partners • Contracts management and maintenance • Operational Budget • Custom Clearance Documentation

On-site Translation: Equipment Installation, Equipment Manuals Translation