Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

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 Republic
09-2019

No Degree - Erasmus, Project in Chemistry

Uppsala University
Uppsala, Sweden
07-2019

Bachelor of Science - Drug Synthesis And Manufacturing

University of Chemistry And Technology
Prague, Czech Republic
06-2017

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
Klaudia Kollarova