Klaudia Kollarova
Amsterdam
Summary
Experienced Regulatory Affairs professional with 5 years of expertise managing end-to-end regulatory activities across diverse product portfolios and development stages. Demonstrated ability to lead lifecycle regulatory strategies, coordinate cross-functional teams, and ensure timely, compliant submissions. Strong foundation in regulatory frameworks and procedures, including centralized and decentralized processes. Holds a Master's and Bachelor's degree in Drug Product Manufacturing. Brings a structured, strategic approach to regulatory planning and execution in dynamic, global environments.
Overview
6
6
years of professional experience
1
1
Certification
Work History
SENIOR ASSOCIATE, GLOBAL REGULATORY AFFAIRS
Covis Pharma Europe B.V.
10.2022 - Current
- Led end-to-end dossier planning and submission management for centralized (CAP), mutual recognition (MRP), and national procedures, including Scientific Advice and Response to Questions coordination with internal teams.
- Ensured regulatory compliance for assigned Marketing Authorizations, acting as the primary RA contact for cross-functional teams; support planning for regulatory meetings and responses to agency questions
- Develop and maintain regulatory timelines, risk mitigation plans, and coordination with internal departments (RA-CMC, QA, PV).
- Conducted regular Product Information reviews, aligning with Core Safety Information (CSI) and evolving EU/UK regulatory requirements.
- Led direct communications with Health Authorities, including submission follow-ups, query responses, and strategic interactions.
- Took initiative in regulatory process improvements, contributing to workflow optimization, compliance enhancements, and cross-functional knowledge sharing across the regulatory affairs team.
REGULATORY AFFAIRS SPECIALIST
B. Braun Medical S.r.o.
07.2021 - 09.2022
- Lead regulatory strategy and execution for multiple medicinal products, including initial Marketing Authorization applications, variations, renewals, and withdrawals in EU markets.
- Acted as primary point of contact for Health Authorities in Slovakia and Czech Republic, managing communication, submission follow-ups, and issue resolution.
- Developed and maintained national product information in alignment with local and EU regulatory frameworks, ensuring accuracy and compliance with evolving guidelines.
- Enabled timely product launches through cross-functional coordination with supply chain, artwork, quality, and commercial teams.
- Oversaw artwork and labelling compliance, including QRD adherence, Blue Box content validation, and national requirements ensuring audit readiness and submission accuracy.
JUNIOR SCIENTIFIC AND REGULATORY SPECIALIST
PrimeVigilance
09.2019 - 06.2021
- Managed regulatory portfolio oversight and lifecycle processes for both biopharmaceutical and generic medicinal products across diverse EU markets.
- Prepared and submitted regulatory applications through MRP, DCP, and national procedures, including end-to-end eCTD compilation, publishing, and CESP submissions.
- Served as a central liaison between Marketing Authorization Holders (MAHs), Contract Manufacturing Organizations (CMOs), and local affiliates to ensure regulatory compliance and timely delivery of regulatory milestones.
- Advised MAHs on optimized, cost-effective regulatory strategies to accelerate approvals while maintaining alignment with regional and local requirements.
- Oversaw submission planning and document readiness to support approval timelines, while proactively identifying risks and mitigation steps throughout the submission lifecycle.
Education
Master of Science - Drug Manufacturing
University of Chemistry And Technology
Prague, Czech Republic09-2019
No Degree - Erasmus, Project in Chemistry
Uppsala University
Uppsala, Sweden07-2019
Bachelor of Science - Drug Synthesis And Manufacturing
University of Chemistry And Technology
Prague, Czech Republic06-2017
Skills
- RA Tools: Veeva Vault, eCTD tools, TrackWise
- EMA Platforms: eSubmission Gateway, ESMP, IRIS, CTIS
- Planning: MS Teams, Outlook, PowerPoint
- Project Management: Microsoft Planner, Excel, Smartsheet
Certification
- Entry Level CMC EU MasterClass, GLC Europe, June 2024
- CRED Managing Lifecycle and Variations Effectively, TOPRA, June 2022
- Active Pharmaceutical Ingredients (APIs) - Up-to-date and comprehensive summary, Conforum, March 2022
- Global Pharmaceutical Regulatory Affairs Summit, TOPRA, September 2020
Timeline
SENIOR ASSOCIATE, GLOBAL REGULATORY AFFAIRS
Covis Pharma Europe B.V.
10.2022 - Current
REGULATORY AFFAIRS SPECIALIST
B. Braun Medical S.r.o.
07.2021 - 09.2022
JUNIOR SCIENTIFIC AND REGULATORY SPECIALIST
PrimeVigilance
09.2019 - 06.2021
Master of Science - Drug Manufacturing
University of Chemistry And Technology
No Degree - Erasmus, Project in Chemistry
Uppsala University
Bachelor of Science - Drug Synthesis And Manufacturing
University of Chemistry And Technology
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