Работала в 3 компаниях 6 лет 1 месяц
Фармацевтика
Regulatory Affairs Specialist
Limited Liability Company ‘Innovative Accounting Systems’, Service Department of AstraZeneca Ukraine LLC
Фармацевтика
1 год 10 месяцев
01.2025 - по настоящее время
- Manage the full life cycle of product compliance and registration processes in alignment with local and international regulatory frameworks.
- Coordinate regulatory workflow for New Product Introductions (NPI) in tight alignment with Supply Chain and Marketing teams.
- Cross-functional collaboration with Supply Chain, Marketing, and Quality Assurance teams to prevent regulatory bottlenecks and ensure business continuity.
- Monitor and analyze changes in local legislation.
- Compile and submit regulatory dossiers and compliance packages for product registrations, ensuring seamless market entry.
- Establish and maintain effective communication with national regulatory bodies, state authorities, and global team to ensure smooth approval processes.
- Conduct internal audits, self-assessments and coordinate compliance training sessions for cross-functional teams to ensure alignment with international quality standards.
- Execute end-to-end artwork compliance verification using a specialized system (Gazelle), ensuring seamless alignment between final packaging, technical mock-ups and legal standards.
Jr. Regulatory Affairs Officer
Limited Liability Company ‘Innovative Accounting Systems’, Service Department of AstraZeneca Ukraine LLC
Фармацевтика
1 год 7 месяцев
06.2023 - 12.2024
- Maintained internal regulatory databases and tracking tools, ensuring high data integrity and precise documentation history.
- Coordinated department budget execution, including purchase order (PO) management and financial document workflow.
- Reviewed product packaging designs and promotional materials.
- Identified/analysed risks and trends, followed up, and implemented corrective and preventive actions (CAPAs).
- Monitored key performance indicators (KPIs) in the relevant area and proposed corrective and improving actions.
- Monitored internal/external factors that may affect regulatory procedures, such as new/updated regulations or changes in regulatory legislation.
- Set and maintained business continuity plans for the department's regulatory activities.
Intern in the Department of Regulatory Affairs and Registration of Cosmetics
GlaxoSmithKline Ukraine / ГлаксоСмітКляйн Україна
Фармацевтика
2 года 8 месяцев
10.2020 - 05.2023
- Proofreading of translations; additional proofreading of instructions for cosmetic use, approval of artworks, and other materials in the systems
- Verification of registration documents and registered details in the RP and information in regulatory trackers, databases and systems
- Record keeping, completion of documentation
- Assisted in the verification and screening of technical documentation, data packages, and certificates of analysis for compliance issues.
- Reconciliation of registered data in the country with information in databases
Ключевая информация
Solution-oriented problem solving
Strong analytical and evaluative capabilities
Ability to work both independently and collaboratively within a team environment
Flexible, adaptable, and able to manage multiple priorities
Highly organized
Strong stakeholder management
Училась в 1 заведении
Biology And Medicine Institute Science Educational Center Of Taras Shevchenko National University Of Kyiv
biology / microbiologist
Kyiv, 2023
Владеет языками
Английский
выше среднего
Немецкий
базовый
Украинский
родной
Дополнительная информация
Tools & Systems
• Specialized Software: Artwork Management Systems (Gazelle), Corporate Document Management Systems, VQV, COUPA, SAP.
• Data & Business Tools: Advanced Excel (data verification), MS Office, Power Point, Adobe, Outlook, spreadsheets, State Registers & Databases.
Анастасія
Анастасія
Product Safety & Regulatory Affairs Specialist
Киев
полная занятость
Характер работы: в офисе/на месте, удаленная работа, гибридная
Последняя активность 3 дня назад