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.
Amsterdam, The Netherlands
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.
Prague, Czech Republic
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
Prague, Czech Republic
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