Nadia Kocik
Krakow
Summary
Detail-oriented professional with a solid background in laboratory research and hands-on experience in global regulatory affairs. Skilled in ensuring compliance with international regulatory standards, supporting product development, and facilitating successful market entry across diverse regions. Known for a strong analytical mindset, meticulous attention to detail, and the ability to bridge the gap between scientific research and regulatory requirements. Committed to advancing health and safety standards while fostering innovation in the global marketplace
Overview
3
3
years of professional experience
Work History
Regulatory Operations Specialist
Reckitt Benckiser Inc.
2023.08 - Current
- Efficient and effective, execution as well as project management of post approval maintenance regulatory activities.
- Ensured successful delivery of assigned projects and activities within agreed timelines.
- Assisted with the product registration globally (EU, ASEAN, AU-NZ, EAEU markets)
- Cooperated with functions such as R&D and Supply within the company to meet the requirements for submissions.
- Involved with the renewal process for drug registrations.
- Responded to Health Authorities questioning for submissions such as Type I and Type II variations, artwork updates (eg. Notification 61(3), etc.
- Experienced in preparing submissions in eCTD, ACTD and NeeS formats.
- Experienced in reviewing and updating templates for submissions.
- Knowledge of regulatory systems such as CARA 3.0 and 5.0 (document management interface), Insight Publisher and LORENZ docuBridge (publishing softwares), QualityOne (quality management system) and LifeSphere RIM (regulatory planning, tracking and registration management)
- Conducted gap analysis for registered dossiers, ensuring that Health Authorities are presented with the most up-to-date drug product information.
- Experienced in reviewing PILs, SmPCs and product artwork.
- Adhered to the SOP and Working Instructions, to ensure the highest quality of work.
- Assisted with Change Controls, Deviations and CAPAs.
Medical Lab Technician
CircularOne Health
2022.07 - 2023.10
- Performed thorough equipment maintenance, ensuring optimal performance and reduced downtime.
- Conferred with patient to obtain information for laboratory records, explain procedures, allay fears and elicit cooperation.
- Improved diagnostic accuracy by performing timely and accurate laboratory tests on patient samples.
- Conducted regular audits of laboratory practices, identifying areas for improvement and implementing corrective actions as needed.
- Performed laboratory testing and operated automated equipment within limits.
- Streamlined sample processing, prioritizing urgent cases for prompt diagnosis and treatment.
Medical Lab Technician With Admin Role
W1 Labs
2022.03 - 2023.07
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
- Trained new technicians on standard operating procedures, ensuring consistency across the team.
- Performed troubleshooting and diagnosis on malfunctioning equipment.
- Completed complex repairs quickly by leveraging strong diagnostic skills and attention to detail.
Laboratory Technician
DnaNudge
2021.05 - 2022.04
- Worked for a new start-up company involved with DNA testing.
- Collected and performed analytical testing on in-process product.
- Prepared detailed documentation for each experiment, facilitating effective communication of results to colleagues and stakeholders.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Hosted lab meetings and project presentations.
- Coordinated the work and responsibilities of laboratory assistants.
Education
Bachelor of Science - Biomedical Sciences
Royal Holloway, University of London
London, UK06.2023
Certificate of Higher Education - Biological Sciences
University of Westminster
London06.2020
Skills
- Project Management
- Risk Mitigation
- Time management abilities
- Cross-Functional Communication
- Knowledge of Regulatory Requirements
- Ability to work with local regulatory affairs globally
- Native English and Polish
- Ability to work with complicated documentation
- Ability to perform big scale gap analysis
- Experienced with the MS Office products
Accomplishments
Coordinated a project funded by "Instytut Rozwoju Jezyka Polskiego" aimed at children of Polish origin living in United Kingdom to propagate Oxford-style debating in Polish.
Timeline
Regulatory Operations Specialist
Reckitt Benckiser Inc.
2023.08 - Current
Medical Lab Technician
CircularOne Health
2022.07 - 2023.10
Medical Lab Technician With Admin Role
W1 Labs
2022.03 - 2023.07
Laboratory Technician
DnaNudge
2021.05 - 2022.04
Bachelor of Science - Biomedical Sciences
Royal Holloway, University of London
Certificate of Higher Education - Biological Sciences
University of Westminster
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