Ewa Gawlik-Perek
Podleze,Poland
Summary
Dynamic and strategic leader with a strong foundation in ethical conduct and decision-making expertise. Demonstrates proficiency in process improvement, Microsoft Excel, and training and development, complemented by an engaging leadership style. Skilled in cross-functional communication, operations planning, and strategy execution, with a focus on customer strategy and service design. Adept at strategic leadership, complex problem resolution, and operational strategy. Committed to leadership development and project portfolio management to drive organisational success.
Offering strong skills in leadership, strategic planning, and team development. Knowledgeable about managing cross-functional teams and driving project success. Ready to use and develop skills in communication, problem-solving, and decision-making in Regulatory Oversight Director role.
Overview
30
30
years of professional experience
Work history
Senior Manager, Regulatory Affairs
ICON, formerly PRA Health Sciences
Warszawa, Poland
2022.06 - 2026.04
- Provide submission strategy to the client along with all requirements and documentation requests to optimize proposed strategy for IMP Clinical Trials as well combined clinical trial that is a simultaneous investigation of IMP and a performance study of the investigational IVD device.
- Overview/ coordinate central independent ethics committee (Central IEC), regulatory agency (RA) and other central or country level authority submissions to ensure contractual timelines are met.
- Prepare/ coordinate preparation of the core clinical trial application and perform QC on the content of all central submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
- Overview tracking and reporting of central submission/approval progress in clinical trials management system (CTMS) and other applicable PRA / ICON systems.
- Perform role of global reviewer in the QC process as appropriate.
- Depending on the scope of the project, create the master IP labels or ensure that sponsor provided IP labels are in adherence with Annex 13 or applicable regional requirements. Coordination of country level labelling translation.
- Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these.
- Successful delivery of ICF template dedicated for IVD performance study performed in combination with IMP trial.
- Successful Submission/Approval process of the Combined Project performed under CTD/CTR for the main IMP Clinical Trial and simultaneously under IVDR for the Performance Study of IVD.
- Oversaw budget preparation and control, ensuring financial discipline within the team.
- Facilitated cross-functional collaboration leading to improved operational efficiency.
- Mentored junior managers, fostering a culture of continuous learning.
- Fostered a positive work environment that encouraged creativity and innovation.
- Directed project management activities for timely delivery of projects.
- Built strong partnerships with stakeholders for mutual benefit.
- Managed daily workflow, delegating tasks to support seamless operations.
Senior Manager, Regulatory Affairs
WORLDWIDE CLINICAL TRIALS POLAND
Warszawa, Poland
2022.02 - 2022.06
- Assist the Site Activation leadership team and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary.
- Support maintenance of the regulatory intelligence database by regularly following any changes in the regulatory legislative requirements.
- Development and delivery of regulatory training sessions.
- Manage regulatory affairs team workload and provide input as to shifting of resources, allocations etc. to respond to projects demand (including holidays approval and proper back-up).
- Conduct routine performance review of line reports and ensure performance feedback is promptly communicated in parallel with coaching.
- Ensure high quality, completeness, consistency and accurate tracking, and prompt filing of submissions and response to queries in accordance with SOP's and regulatory guidelines.
- Provide expert regulatory knowledge with the Site Activation functional leads and the rest of project team to establish risk mitigation strategies/contingency plans and present these to sponsors.
- Ensure high quality performance of deliverables are applied within the projects assigned to line reports and promptly identify and address any risk/potential risk by implementing preventive measures and mitigation plans in collaboration with the Site Activation Manager.
- Support training and guidance for junior members of the Regulatory Affairs team (including EUCTR).
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers.
- Oversee the activities of assigned Regulatory Specialists to ensure critical path activities are completed on time and ensures optimal start and conduction of regulatory affairs activities to meet project deliverables.
- Communicate the submission status to the Sponsor, Global Project Lead (GPL) and relevant functional leads.
- Prepare, publish, and review core regulatory, scientific, technical and administrative documentation necessary for enabling study initiation and maintenance. Review and make expert recommendations on all relevant study regulatory documentation e.g. labels, patient information sheets, diary cards etc. to ensure compliance with ICH GCP.
- Provide a regulatory management of the project. Provide strategic and regulatory consultancy and scientific support on a variety of projects. Determine regulatory strategy/expectation and parameters for necessary authorizations.
- Successful delivery of label text for co-packaged and integrated Drug/Device Combination Products
Regulatory Affairs Manager/Regulatory Advisor (RAd)
IQVIA (FORMER QUINTILES)
Warszawa, Poland
2017.12 - 2022.01
- Oversight RAd for Strategic Sponsor.
- Cooperate directly with the sponsor on the account level. Participate in Partnership Outsourcing Manual creation as well Project Specific Manual creation for the partner.
- Participate and manage oversight meetings with the partner for regulatory related items like EUCTR, ICF or delegation documentation development. Oversight and support as needed all studies for the partner.
- Support others in special interest area like Medical Device/Combine Products items, Delegation Letters creation, training plan/platform.
- Mentor and coach colleagues as required.
- Closely cooperate with Start-up team to meet expected timelines.
- Prepare, publish, and review core regulatory, scientific, technical and administrative documentation necessary for enabling study initiation and maintenance. Perform QC check for all regions, develop Master ICF for global studies.
- Provide a regulatory and technical management of the project. Provide strategic and regulatory consultancy and scientific support on a variety of projects. Determine regulatory strategy/expectation and parameters for necessary authorizations.
- Creation of the ICF Project Instruction for Strategic Sponsor Trials based on Partnership Agreement.
- Close cooperation with Strategic Sponsor for the Sponsor-CRO readiness for the EUCTR and CTIS submissions.
- Expedited, successful Submission/Approval process for COVID-19 vaccine study.
- Oversight outsourced Partner Sponsor Studies based on Partnership Agreement, including coordination of MHRA submissions of UK MIA Holder for all outsourced trials.
Regulatory & Start-Up Manager
IQVIA (FORMER QUINTILES)
Warszawa, Poland
2010.05 - 2017.11
- Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
- Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
- Participate in BID and proposal development.
- Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
- Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
- Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
- Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Manage the team. Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
- Oversight and execution of Start Up Globally (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
- Development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
- Active management of start-up activities reasoning in sponsor satisfaction and award obtaining.
- Active and timely management of ICF country adaptation.
- Active and timely management of label country adaptation.
- Active and timely management of country Delegation Letter/LoA preparation.
Principal, Senior Clinical Research Associate
IQVIA (FORMER QUINTILES)
Warszawa, Poland
2006.12 - 2010.06
- Provide Clinical Team Lead (CTL) and line managers metrics on team members' monitoring quality.
- In conjunction with the CTL, create tools, procedures and processes for study team to ensure quality monitoring.
- Act as a trainer and mentor for clinical staff. Conduct quality assessment and training visits for a variety of protocols and study teams.
- Act as a designated trainer within a specific client assignment working with clinical team and clinical operations management to develop quality monitoring practices across studies.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to the appropriate team.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas.
- Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Take special assignments related to corporate initiatives. Act as a trainer in CRA school - lecture topics related SDV and e-CRF.
- Active management of CRA activities reasoning in sponsor satisfaction and award obtaining.
Clinical Research Associate
KRAKOW CARDIOVASCULAR RESEARCH INSTITUTE
Kraków, Poland
2004.11 - 2006.11
- Phase IV for AMI with medical devices - drag-eluting stents (20 patients/2 sites -Monitoring Visits)
- Phase IV for AMI with medical devices - blood clot pump (40 patients/3 sites - Monitoring Visits)
- Clinical Research Associate responsibilities for:
- Phase III for AMI with drugs - platelet aggregation inhibitor-IIb/IIIa blockers (300 patients/10 sites - Monitoring Visits, Close-out Visits)
Nurse, Study Nurse, Site Coordinator
Department of Haemodynamic and Angiocardiography, Institute of Cardiology, University Hospital
Kraków, Poland
2003.01 - 2006.11
- 3 years experience on Acute Care with patients with Acute Coronary Syndrome
- Study nurse responsibilities at study with medical devices used in Artherioplasty (stents, drug-eluting stents [DES], multi-vessel stents, blood clot pump) and study with drugs in Acute Myocardial Infarction (platelet aggregation inhibitor-IIb/IIIa blockers, thrombolytic drugs)
- Site coordinator responsibilities at study with medical devices (endothelial contractility examination)
Nurse
Department of Burn and Restorative Surgery with ICU, Specialist Hospital
Kraków, Poland
1995.11 - 2002.12
- 5 years experiences on Acute Care department with Burn Patients
- Nurse, burn and surgical nurse
Education
Graduate, Nurse - Nursing
Liceum Medyczne im. Hanny Chrzanowskiej w Krakowie (Medical School)
Kraków, Małopolskie, PolandBurn/surgical nurse - Nursing
District Hospital
Siemianowice Śląskie, Śląskie, PolandGraduate, Engineer - Geology
Academy of Mining and Geology Faculty of Geology, Geophysics, Environmental Engineering
Kraków, Małopolskie, PolandGraduate, Master of Science - Environmental engineering
Academy of Mining and Geology Faculty of Geology, Geophysics, Environmental Engineering
Kraków, Małopolskie, PolandMonitor - postgraduate training - Monitoring of clinical trials in Poland- Polish regulations
Monipol - Contract Research & Medical Consultants
Kraków, Małopolskie, PolandMonitor - postgraduate training - Monitoring of clinical trials in Poland part 2, American, European and Polish law regulations
CRDE Sp. J.
Warszawa, Mazowieckie, PolandSkills
- Ethical conduct
- Decision-Making expertise
- Process improvement knowledge
- Microsoft Excel
- Training and Development
- Engaging leadership style
- Cross-functional communication
- Operations planning
- Strategy execution
- Customer strategy and service design
- Strategic leadership
- Complex problem resolution
- Strategic thinking
- Operational strategy
- Leadership development
- Project portfolio management
Languages/Fluency
English: High Conversational, High Reading, High Writing, High Terminology
Fluent
Polish: High Conversational, High Reading, High Writing, High Terminology
Native
Publications
- Demystifying EU Regulations on Clinical Trials: A blueprint for EU CTR, MDR and IVDR submissions, Coauthor of the Whitepaper, Whitepaper published on the ICON web page: https://www.iconplc.com/insights/regulatory-intelligence/demystifying-eu-ctr-mdr-and-ivdr Authors: Sorina Gherghe, Ewa Gawlik-Perek, Laura van Vaeck, Shanna Hurts, 2024
- Integrating performance studies of In-Vitro Diagnostics into clinical trials: A Complex Challenge, Coauthor of the Blog, Blog published on the ICON web page: https://www.iconplc.com/insights/blog/2024/05/10/integrating-performance-studies-vitro-diagnostics-clinical-trials-complex?utm_source=linkedin&utm_medium=organic&utm_campaign=blg-2024 Authors: Sorina Gherghe, Ewa Gawlik-Perek, Laura van Vaeck, Shanna Hurts, 2024
- Defining the differences when regulating medical devices, medicinal and combination products, Coauthor of the Blog, Blog published on the ICON web page: https://www.iconplc.com/insights/blog/2024/07/10/defining-differences-when-regulating-medical-devices-medicinal?utm_source=linkedin&utm_medium=organic&utm_campaign=blg-2024, 2024
Affiliations
- swimming and diving, skiing,
- Hwa Rang Do student
- garden passionate
- spending free time on several activities
Summary
Over 23 years' experience working in Clinical Research including 2 years as a Site Coordinator, over 5 years in clinical monitoring as a Clinical Research Associate in large studies with a variety of investigational drugs and medical devices.
Thereafter over 7 years on the position of Global Regulatory and Start-up Manager in large multi-national studies (phase II, III, IV) across Europe, APAC, North-Latin America with a variety of investigational drugs and finally over 8 years on the global position of Regulatory Affairs Manager/Senior Regulatory Affairs Manager with the Oversight Regulatory Advisor role for Strategic Sponsor and over 4 years working on studies with MD and IVD assays in combination with the IMP clinical trials and becoming Subject Matter Expert in such combinations.
Responsibilities have spanned the full duration of studies, from pre-award/bid defense activities, through start-up, monitoring, to project close-out and archiving with experience of participation in audits.
Extensive experience in mentoring of other CRAs/RSULs/RAMs and team members; performing lectures, trainings and accompanied Site Visits as well team managing on regional and global level.
Significant experience working in the therapeutic area of: internal medicine (cardiovascular diseases, RA-biological therapy, gastrointestinal diseases), neurology, oncology, gynecology, pediatry, pulmonology, psychiatry or infection diseases including COVID vaccines. Experience in drug/device combination product investigation and Post-Market Clinical Follow Up (PMCF) in accordance of MDR. Experience in drug/IVD combination studies in accordance of IVDR.
Protocol Therapeutic Experience
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Arrhythmia, Primary Indication: Atrial Arrhythmia, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: IV, Subject Population: ADULTS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Atherosclerosis, Primary Indication: Valvulopathy, Role: Registered Nurse, Number of Studies: 1, Duration: 2 yrs, 0 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Coronary Artery Disease, Primary Indication: Myocardial Infarction, Role: Registered Nurse, Number of Studies: 1, Duration: 2 yrs, 5 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Coronary Artery Disease, Primary Indication: Myocardial Infarction, Role: Registered Nurse, Number of Studies: 1, Duration: 2 yrs, 10 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Coronary Artery Disease, Primary Indication: Myocardial Infarction, Role: Clinical Research Associate, Number of Studies: 1, Duration: 1 yr, 0 mos, Phase: IV, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Pulmonary Hypertension, Primary Indication: Pulmonary Hypertension, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 3 yrs, 9 mos, Phase: III, Subject Population: Cardiovascular Subjects;ADULTS
- Therapeutic Area: Endocrinology, Indication Group: -, Primary Indication: Hyperthyroidism, Role: Senior Manager, Regulatory Affairs, Number of Studies: 1, Duration: 1 yr, 6 mos, Phase: IIB, Subject Population: African-American; Asian;Caucasian; Hispanic
- Therapeutic Area: Gastroenterology, Indication Group: Esophageal Disorders, Primary Indication: GERD, Role: Clinical Research Associate, Number of Studies: 1, Duration: 2 yrs, 0 mos, Phase: II, Subject Population: PEDIATRICS
- Therapeutic Area: Haematology, Indication Group: Lymphoma, Primary Indication: Diffuse Large B-Cell Lymphoma (DLBCL), Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: I, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Crohn's Disease, Role: Clinical Research Associate, Number of Studies: 1, Duration: 1 yr, 11 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Crohn's Disease, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 0 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Lupus Nephritis, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Rheumatoid Arthritis, Role: Clinical Research Associate, Number of Studies: 1, Duration: 1 yr, 11 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Rheumatoid Arthritis, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 11 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Autoimmune Disorders, Primary Indication: Ulcerative Colitis, Role: Clinical Research Associate, Number of Studies: 1, Duration: 11 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Immunology, Indication Group: Rheumatology, Primary Indication: Rheumatoid Arthritis, Role: Senior Manager, Regulatory Affairs, Number of Studies: 1, Duration: 1 yr, 6 mos, Phase: IIB, Subject Population: Rheumatic Subjects
- Therapeutic Area: Infectious Diseases, Indication Group: Antibacterials, Primary Indication: Bacterial Infections, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 9 mos, Phase: II, Subject Population: PEDIATRICS
- Therapeutic Area: Infectious Diseases, Indication Group: Antibacterials, Primary Indication: Bacterial Infections, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: III, Subject Population: ADULTS; Female Only; Post-menopausal; ADULTS
- Therapeutic Area: Infectious Diseases, Indication Group: Vaccines, Primary Indication: Coronavirus Disease (COVID-19), Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 2 yrs, 3 mos, Phase: II, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Neurology, Indication Group: Mental Disorders, Primary Indication: Autism Spectrum Disorder (ASD), Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: II, Subject Population: PEDIATRICS
- Therapeutic Area: Neurology, Indication Group: Movement Disorders, Primary Indication: Parkinson's Disease, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 4 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Neurology, Indication Group: Pain, Primary Indication: Headache, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 4 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Neurology, Indication Group: Seizure, Primary Indication: Epilepsy, Role: Clinical Research Associate, Number of Studies: 1, Duration: 1 yr, 11 mos, Phase: III, Subject Population: ADULTS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Breast, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 11 mos, Phase: IIIB, Subject Population: Female Only;Post-menopausal; ADULTS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Esophageal, Role: Senior Manager, Regulatory Affairs, Number of Studies: 1, Duration: 3 yrs, 9 mos, Phase: III, Subject Population: Adults
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Liver Metastases, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 9 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Liver Metastases, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 3 mos, Phase: UNDEFINED, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: NSCLC, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 0 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Oncology, Indication Group: Solid Tumors, Primary Indication: Prostate, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 10 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Psychiatry, Indication Group: Mood Disorders, Primary Indication: Depression, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 4 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Psychiatry, Indication Group: Mood Disorders, Primary Indication: Major Depressive Disorder (MDD), Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 2 yrs, 8 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Psychiatry, Indication Group: Mood Disorders, Primary Indication: Major Depressive Disorder (MDD), Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 11 mos, Phase: III, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Psychiatry, Indication Group: Psychoses, Primary Indication: Schizophrenia, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 10 mos, Phase: II, Subject Population: ADULTS
- Therapeutic Area: Psychiatry, Indication Group: Psychoses, Primary Indication: Schizophrenia, Role: Mgr of Global Reg Affairs, Number of Studies: 1, Duration: 1 yr, 0 mos, Phase: III, Subject Population: ADULTS
Non-Protocol Therapeutic Experience
- Therapeutic Area: Cardio-Metabolic Diseases, Indication Group: Coronary Artery Disease, Primary Indication: Myocardial Infarction, Job Title: Nurse, Study Nurse, Site Coordinator, Duration: 3 yrs, 10 mos, Subject Population: ADULTS; GERIATRICS
- Therapeutic Area: Oncology (Solid Tumors), Indication Group: Gi Tumors, Primary Indication: Gastric Cancer, Job Title: Senior Manager, Regulatory Affairs, Duration: 3 yrs, 9 mos, Subject Population: Oncology Subjects
- Therapeutic Area: Surgical, Indication Group: Cosmetic, Primary Indication: Plastic Surgery, Job Title: Nurse, Duration: 7 yrs, 1 mo, Subject Population: ADULTS; GERIATRICS
Geographic Experience
- Country or Region: Argentina, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Immunology, Infectious Diseases, Psychiatry, Role: Mgr of Global Reg Affairs,Senior Manager, Regulatory Affairs
- Country or Region: AUSTRALIA, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: AUSTRIA, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Immunology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Belgium, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Haematology, Immunology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs,Senior Manager, Regulatory Affairs
- Country or Region: BRAZIL, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Bulgaria, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Immunology, Psychiatry, Role: Mgr of Global Reg Affairs,Senior Manager, Regulatory Affairs
- Country or Region: CANADA, Therapeutic Area: Cardio-Metabolic Diseases, Neurology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: CHILE, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: CHINA, Therapeutic Area: Cardio-Metabolic Diseases, Role: Mgr of Global Reg Affairs
- Country or Region: COLOMBIA, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: CROATIA, Therapeutic Area: Immunology, Oncology, Psychiatry, Role: Senior Manager, Regulatory Affairs
- Country or Region: CZECH REPUBLIC, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Immunology, Infectious Diseases, Neurology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Czechia, Therapeutic Area: Immunology, Role: Senior Manager, Regulatory Affairs
- Country or Region: DENMARK, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Neurology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: ESTONIA, Therapeutic Area: Oncology, Role: Mgr of Global Reg Affairs
- Country or Region: France, Therapeutic Area: Infectious Diseases, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs
- Country or Region: Georgia, Therapeutic Area: Endocrinology, Immunology, Role: Senior Manager, Regulatory Affairs
- Country or Region: Germany, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Haematology, Immunology, Infectious Diseases, Neurology, Psychiatry, Role: Mgr of Global Reg Affairs,Senior Manager, Regulatory Affairs
- Country or Region: Greece, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs,Senior Manager, Regulatory Affairs
- Country or Region: INDIA, Therapeutic Area: Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: IRELAND, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: ISRAEL, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Immunology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Italy, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Haematology, Immunology, Infectious Diseases, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs,Senior Manager, Regulatory Affairs
- Country or Region: JAPAN, Therapeutic Area: Cardio-Metabolic Diseases, Role: Mgr of Global Reg Affairs
- Country or Region: LATVIA, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Lithuania, Therapeutic Area: Cardio-Metabolic Diseases, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs
- Country or Region: MALAYSIA, Therapeutic Area: Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: MEXICO, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: NETHERLANDS, Therapeutic Area: Cardio-Metabolic Diseases, Haematology, Infectious Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: NORTH KOREA, Therapeutic Area: Cardio-Metabolic Diseases, Role: Mgr of Global Reg Affairs
- Country or Region: PERU, Therapeutic Area: Cardio-Metabolic Diseases, Infectious Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Poland, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Gastroenterology, Haematology, Immunology, Infectious Diseases, Neurology, Oncology, Oncology (Solid Tumors), Psychiatry, Surgical, Role: Clinical Research Associate, Mgr of Global Reg Affairs, Nurse, Nurse, Study Nurse, Site Coordinator, Senior Manager, Regulatory Affairs
- Country or Region: Portugal, Therapeutic Area: Cardio-Metabolic Diseases, Neurology, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs
- Country or Region: PUERTO RICO, Therapeutic Area: Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Romania, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Neurology, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs,Senior Manager, Regulatory Affairs
- Country or Region: RUSSIA, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SERBIA, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SINGAPORE, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SLOVAKIA, Therapeutic Area: Cardio-Metabolic Diseases, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SOUTH AFRICA, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SOUTH KOREA, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: Spain, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Immunology, Infectious Diseases, Oncology, Oncology (Solid Tumors), Psychiatry, Role: Mgr of Global Reg Affairs, Senior Manager, Regulatory Affairs
- Country or Region: SWEDEN, Therapeutic Area: Immunology, Infectious Diseases, Neurology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: SWITZERLAND, Therapeutic Area: Cardio-Metabolic Diseases, Role: Mgr of Global Reg Affairs
- Country or Region: TAIWAN, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: THAILAND, Therapeutic Area: Cardio-Metabolic Diseases, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: TURKEY, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: UKRAINE, Therapeutic Area: Cardio-Metabolic Diseases, Infectious Diseases, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: UNITED KINGDOM, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Infectious Diseases, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: United Kingdom of Great Britain and Northern Ireland (the), Therapeutic Area: Endocrinology, Immunology, Role: Senior Manager, Regulatory Affairs
- Country or Region: UNITED STATES, Therapeutic Area: Cardio-Metabolic Diseases, Immunology, Infectious Diseases, Oncology, Psychiatry, Role: Mgr of Global Reg Affairs
- Country or Region: United States of America (the), Therapeutic Area: Endocrinology, Immunology, Role: Senior Manager, Regulatory Affairs
- Country or Region: CANADA, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: CENTRAL EUROPE, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: EASTERN ASIA, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: EASTERN EUROPE, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: LATIN AMERICA, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: MIDDLE EAST, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: OCEANIA, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: UNITED STATES, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: WESTERN ASIA, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
- Country or Region: WESTERN EUROPE, Therapeutic Area: Oncology, Role: Senior Manager, Regulatory Affairs
Drug Type Experience
- Drug Type: Biologic (other not listed), Therapeutic Area: Endocrinology, Immunology, Subject Population: ADULTS, GERIATRICS, African-American;Asian; Caucasian;Hispanic, Rheumatic Subjects
- Drug Type: Chemical Entity, Therapeutic Area: Cardio-Metabolic Diseases, Gastroenterology, Haematology, Immunology, Infectious Diseases, Neurology, Oncology, Psychiatry, Subject Population: ADULTS, GERIATRICS, Cardiovascular Subjects; ADULTS, Female Only; ADULTS, Female Only; Post-menopausal; ADULTS, PEDIATRICS
- Drug Type: mAntibody (imm checkpoints), Therapeutic Area: Oncology, Subject Population: ADULTS
- Drug Type: Vaccine (infectious disease), Therapeutic Area: Infectious Diseases, Subject Population: ADULTS, GERIATRICS
- Device: Therapeutic Area: Cardio-Metabolic Diseases, Neurology, Pulmonology, Oncology, Subject Population: ADULTS, GERIATRICS
- IVD: Therapeutic Area: Internal Medicine, Pulmonology, Oncology, Subject Population: ADULTS, GERIATRICS
Environment Experience
- Environment: Critical Care, Therapeutic Area: Cardio-Metabolic Diseases, Surgical, Subject Population: ADULTS, ADULTS;GERIATRICS
- Environment: Doctor's Office, Therapeutic Area: Gastroenterology, Immunology, Infectious Diseases, Neurology, Oncology, Psychiatry, Subject Population: ADULTS, ADULTS;GERIATRICS, Female Only;ADULTS, Female Only;Post-menopausal;ADULTS, PEDIATRICS
- Environment: Emergency Room, Therapeutic Area: Cardio-Metabolic Diseases, Surgical, Subject Population: ADULTS, ADULTS;GERIATRICS
- Environment: Home Care, Therapeutic Area: Endocrinology, Immunology, Subject Population: African-American;Asian;Caucasian; Hispanic, Rheumatic Subjects
- Environment: In-patient, Therapeutic Area: Cardio-Metabolic Diseases, Endocrinology, Gastroenterology, Haematology, Immunology, Infectious Diseases, Neurology, Oncology, Oncology (Solid Tumors), Psychiatry, Subject Population: ADULTS, ADULTS;GERIATRICS, African-American;Asian;Caucasian;Hispanic, Cardiovascular Subjects;ADULTS, Female Only;Post-menopausal;ADULTS, Oncology Subjects, PEDIATRICS, Rheumatic Subjects
- Environment: Out-patient, Therapeutic Area: Cardio-Metabolic Diseases, Gastroenterology, Haematology, Subject Population: ADULTS, ADULTS;GERIATRICS, Cardiovascular Subjects;ADULTS, Female
System Experience
- Type: Clinical Trial Management Systems, System Name: Siebel Clinical (CTMS), Veeva Vault Clinical
- Type: Early Clinical System, System Name: Mortara Eilink (ECG)
- Type: EDC, System Name: Medidata RAVE, Oracle Inform
- Type: IVRS/IWRS/RTSM, System Name: Cenduit, ClinPhone IVRS, Suvoda IRT
- Type: Safety, System Name: PV Monitoring
- Type: TMF, System Name: Veeva Vault ETMF
Vendor Experience
- Type: Central Lab Services, Name: LabCorp, Covance
- Type: Drug Packaging & Distribution, Name: ThermoFisher
- Type: Other, Name: SCOUT
- Type: Translation Services, Name: TransPerfect
Timeline
Senior Manager, Regulatory Affairs
ICON, formerly PRA Health Sciences
2022.06 - 2026.04
Senior Manager, Regulatory Affairs
WORLDWIDE CLINICAL TRIALS POLAND
2022.02 - 2022.06
Regulatory Affairs Manager/Regulatory Advisor (RAd)
IQVIA (FORMER QUINTILES)
2017.12 - 2022.01
Regulatory & Start-Up Manager
IQVIA (FORMER QUINTILES)
2010.05 - 2017.11
Principal, Senior Clinical Research Associate
IQVIA (FORMER QUINTILES)
2006.12 - 2010.06
Clinical Research Associate
KRAKOW CARDIOVASCULAR RESEARCH INSTITUTE
2004.11 - 2006.11
Nurse, Study Nurse, Site Coordinator
Department of Haemodynamic and Angiocardiography, Institute of Cardiology, University Hospital
2003.01 - 2006.11
Nurse
Department of Burn and Restorative Surgery with ICU, Specialist Hospital
1995.11 - 2002.12
Burn/surgical nurse - Nursing
District Hospital
Graduate, Engineer - Geology
Academy of Mining and Geology Faculty of Geology, Geophysics, Environmental Engineering
Graduate, Master of Science - Environmental engineering
Academy of Mining and Geology Faculty of Geology, Geophysics, Environmental Engineering
Monitor - postgraduate training - Monitoring of clinical trials in Poland- Polish regulations
Monipol - Contract Research & Medical Consultants
Monitor - postgraduate training - Monitoring of clinical trials in Poland part 2, American, European and Polish law regulations
CRDE Sp. J.
Graduate, Nurse - Nursing
Liceum Medyczne im. Hanny Chrzanowskiej w Krakowie (Medical School)