Sr. Clinical Trial Regulatory Affairs Lead at Roche (2022-07 – Present)
Senior leadership role in clinical trial regulatory affairs with EU and global scope
- Act as Submission and Strategic Regulatory Lead for the EU Part I submissions under Regulation (EU) No 536/2014 via CTIS, driving strategy, coordination, and harmonized execution across Member States
- Core member of the submission strategy group, partnering with the Global Regulatory Lead (GRAL) to design and implement submission strategies for all participating RoW countries
- Ensure global-to-local regulatory alignment, adapting submission approaches to diverse regional requirements while maintaining consistency with global development strategy
- Serve as key interface with EU Health Authorities (Part I focus), managing scientific dialogue and regulatory responses
- Provide strategic regulatory guidance to senior leadership, translating evolving EMA and regional requirements into actionable development strategy
- Mentor and develop regulatory professionals, elevating regulatory capability across global teams
- Act as RIM Superuser, supporting regulatory systems, compliance, and process optimization
SIA Team Manager at PPD Hungary Ltd. (2020-09 – 2022-08)
Management role for Site Initiation Activities team
- being the first point of contact to the different Sponsors
- Manage the site start up process until all participating sites got activated
- Collaborate and communicate with stakeholders to ensure timely delivery of site start up activities
- Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting
- Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time
- Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF customization, Risk Mitigations, IMP Release Requirements and Contract Execution
- proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines
Sr. Country Approval Specialist at PPD (2015-06 – 2022-08)
Senior specialist role in country regulatory approvals
- Prepare, review and coordinate local regulatory submissions to the Ministry of Health and Central Ethics Committee for approval following the national regulations
- Coordinate with internal functional departments, and international project team members to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines
- Ensures the submission process for sites and studies are aligned to the critical path for site activation
- To care about activities and task for ensuring site activation in timely manner
Principal Country Approval Specialist at PPD (2019-04 – 2020-09)
Principal level role in country approvals
Special Assignment STM at PPD (2019-01 – 2020-09)
Special assignment in site team management
Country Approval Specialist at PPD (2013-01 – 2015-12)
Country approval specialist role
- Prepare, review and coordinate local regulatory submissions to the Ministry of Health and Central Ethics Committee for approval following the national regulations
- Coordinate with internal functional departments, and international project team members to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines
- Ensures the submission process for sites and studies are aligned to the critical path for site activation
- To care about activities and task for ensuring site activation in timely manner
- Serve as a key contact at country level for either Ethical or Regulatory submission related activities and for Project Team Members
- Responsible for managing translations and proceed with translation reviews
- Keeping track of activities and task done in the projects
Clinical Submission Specialist at PPD (2012-01 – 2013-12)
Clinical submission specialist role
- Performed and coordinated all activities required to submit and obtain Regulatory Authority Approval and Ethics Committee favorable opinion for projects running in Hungary
- Served as a contact with Regulatory authorities, and Ethics Committee Liaised with assigned Regulatory Affairs representative(s) to obtain master regulatory package
Project Assistant at PPD (2012-06 – 2012-12)
Project administrative support
- Provided project administrative support to Clinical Team Managers, Project Managers Project Team Members on designated projects. Responsible for the background administration and preparation for trial set up, monitoring tracking and close out
HR & Payroll Advisor (French language) at NorthgateArinso, Inc. (2011-11 – 2012-06)
HR and Payroll advisory role
- Maintained various payroll records, prepared salary and wage payrolls, gathered and analysed payroll data, interpreted, explained and recommended changes relating to payroll. Responded to queries for workers living in France
Database Associate at Cegedim Hungary Ltd (2005-01 – 2011-12)
Database management and client support
- According to the clients' demands updated data bases, created monthly reports. Attended meetings and reunions with the clients. Handled reclamations coming from the clients' side
