MAGDALENA CIMPEAN
Brussels
Summary
Senior Regulatory Specialist with extensive experience in European regulatory affairs and global CROs. Developed a network of over 500 professionals and effectively navigated complex regulatory environments, including the European Medicines Agency and Clinical Trial Information System. Proficient in regulatory strategy development, submission management, and compliance assurance. Strong communicator and problem-solver, dedicated to supporting team objectives and organizational standards.
Overview
17
17
years of professional experience
Work History
SENIOR REGULATORY SPECIALIST
Precision Medicine Group
Brussels Region
03.2024 - Current
- Monitored emerging regulatory developments to ensure compliance and adapt strategies effectively.
- Simplified ICH-GCP, EU CTR, and Eudravigilance content for external stakeholders to enhance understanding.
- Analyze specific research data to identify trends, opportunities, and challenges that inform decision-making.
- Prepare detailed reports summarizing research outcomes and regulatory updates for internal review.
- Collaborate with cross-functional teams to integrate research findings into ongoing projects.
- Created engaging presentations to convey findings and insights from research projects to stakeholders.
- Utilized Tableau to process and visualize study data for better insights.
- Proficient user of the Microsoft Office at an experienced level, with a strong focus on the Adobe Suite.
- Elevate stakeholders and vendor management and develop a lean communication strategy.
REGULATORY SPECIALIST
Fortrea (formerly Labcorp)
Brussels Region
11.2022 - 03.2023
- Analyze regulatory guidance and reflection papers to ensure compliance and inform strategic decisions.
- Monitor and summarize key changes in regulations, providing insights and recommendations to stakeholders.
- Drafted comprehensive reports on regulatory developments, outlining implications for current and future projects.
- Draft country ICF's, site specific ICF's and other submission documents.
- Coordinate training meetings and on-site communication about safety issues and deadlines.
- Achieved recognition from global customers for analytical efficiency and speed.
- Operational excellence yielding a 20% operational benefit.
- Contributed to a 187% increase in branch annual turnover through the implementation of after-sales customer follow-up.
- Managed team performance and development, contributing to a 5% decrease in employee turnover.
REGULATORY ASSOCIATE
Marken
Zaventem Region
03.2020 - 11.2022
- Coordinated training and development for six Study Set-up Associates and regional quality coordinator to enhance team readiness.
- Maintain and update data in seven quantitative and qualitative reports, submitting them to federal sub-commissions (COCOM and COCOF).
- Provide daily reports on quality issues and cancellation costs.
- Managed 220 emails daily to support communication and coordination for 134 active clinical trials.
- Organize the planning and all level communication for project management during COVID-19 testing (first and second wave).
- Plan and manage weekly test deliveries for twenty-three testing centers in Brussels and Wallonia.
- Coordinated the distribution of PCR tests to 820 nursing homes in Brussels and Wallonia to facilitate timely testing.
Local Product Owner
BISNODE
Brussels
06.2015 - 03.2020
- Prioritized product backlog to align features with stakeholder feedback and market research insights.
- Collaborated with cross-functional teams to achieve shared understanding and alignment on product goals.
- Facilitated agile ceremonies to enhance team communication and efficiency.
Policy Advisor
EFN
Brussels
08.2015 - 04.2017
- Guided policy formulation and implementation by identifying best practices and aligning strategies with organizational goals.
- Assessed policy effectiveness and implications through comprehensive impact evaluations.
- Monitored legislative changes affecting organizational goals and strategies.
- Drafted concise policy briefs that informed senior leadership decision-making.
Public Healthcare Officer
VRGT
Brussels
02.2014 - 08.2015
- Coordinated team schedules to optimize workflow and effectively allocate resources.
- Implemented process improvements that enhanced service delivery and operational performance metrics.
- Collaborated with cross-functional teams to streamline communication and project execution.
- Facilitated team meetings to address challenges, share updates, and establish best practices in operations.
- Participated in regular meetings with upper management regarding progress updates on current initiatives.
- Implemented new technologies to enhance workplace productivity levels.
Digital coordinator
HTW
Asse
09.2010 - 02.2014
- Created and revised marketing policies and procedures to enhance team effectiveness.
- Recommended policy changes to refine marketing tactics and strategies for better alignment with goals.
- Evaluated marketing personnel, providing constructive feedback to support professional development.
Regional Marketing Director
BDM Pharma
Cluj-Napoca
12.2008 - 09.2010
- Conducted market research to pinpoint healthcare trends and customer needs, informing targeted marketing strategies.
- Monitored regional market trends to identify opportunities for growth or expansion.
- Conducted research on competitors' activities in the region.
- Developed promotional content, including brochures, flyers, and digital ads, to enhance brand visibility and engagement.
- Trained and mentored junior marketing staff on best practices, fostering a knowledgeable team capable of executing effective marketing initiatives.
- Mentored marketing personnel on best practices and protocols to maximize productivity.
Education
BA - MARKETING
Medicine University -Babes Bolyai
Cluj- Napoca, Romania09.2009
BA - HEALTHCARE MANAGEMENT
Medicine University -Iuliu Hatieganu
Cluj- Napoca, Romania09.2008
MA - MANAGEMENT AND MARKETING
Solvay Business School
Bruxelles, BelgiumMA - POLITICAL SCIENCE
UCL Louvain
Louvain La Neuve, BelgiumSkills
- Data analytics
- Records search
- Legal writing
- Excellent communication
- Organized
- Project coordination
- Cross-team collaboration
- Policy formulation
- Stakeholder management
Languages
- Dutch
- French
- German
- English, C2 (native proficiency)
- Dutch, C1 (working proficiency)
- French, B2+ (proficiency)
- German, B2+ (proficiency)
Timeline
SENIOR REGULATORY SPECIALIST
Precision Medicine Group
03.2024 - Current
REGULATORY SPECIALIST
Fortrea (formerly Labcorp)
11.2022 - 03.2023
REGULATORY ASSOCIATE
Marken
03.2020 - 11.2022
Policy Advisor
EFN
08.2015 - 04.2017
Local Product Owner
BISNODE
06.2015 - 03.2020
Public Healthcare Officer
VRGT
02.2014 - 08.2015
Digital coordinator
HTW
09.2010 - 02.2014
Regional Marketing Director
BDM Pharma
12.2008 - 09.2010
BA - MARKETING
Medicine University -Babes Bolyai
BA - HEALTHCARE MANAGEMENT
Medicine University -Iuliu Hatieganu
MA - MANAGEMENT AND MARKETING
Solvay Business School
MA - POLITICAL SCIENCE
UCL Louvain