Karolina Mazurek, EMBA in

Karolina Mazurek, EMBA

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Regulatory Affairs Manager, Regional Regulatory Lead (US & EU), MPR Excellence Group at Freyr Solutions
📍 Poland

Karolina is a strategic Regulatory Affairs Manager and Regional Lead for the US & EU at Freyr Solutions, with over 15 years of experience in global organizations. Holding an EMBA from SGH Warsaw School of Economics, she specializes in leading cross-functional teams and ensuring regulatory compliance for product development and lifecycle management.

She is deeply invested in personal and professional growth, having completed certified development paths in Emotional Intelligence to foster authentic leadership. Karolina actively engages with new technologies and methodologies to enhance her expertise, demonstrated by her pursuit of courses in AI and clinical trials.

Unique fact: Karolina is an AI Ambassador, actively promoting the use of AI-driven solutions to optimize regulatory workflows and simplify compliance.

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Current Role
Regulatory Affairs Manager, Regional Regulatory Lead (US & EU), MPR Excellence Group
Location
Poland
Personality Overview

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Priorities

Topics Karolina cares about

AI in Regulatory
As an "AI Ambassador, " she actively promotes AI-powered tools like Freyr's "freya fusion" chatbot to streamline regulatory processes and enhance compliance efficiency.
Global Regulatory Strategy
Her role as Regional Lead for the US & EU involves defining and executing regulatory strategies, acting as the primary liaison with health authorities like the FDA and EMA.
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Career

Work history

9-2025
Regulatory Affairs Manager, Regional Regulatory Lead (US & EU), MPR Excellence Group
Freyr Solutions
5-2021 - 9-2025
Program Manager at Bioton, PMO Head
BIOTON S.A.
3-2020 - 5-2021
Senior Regulatory Affairs Specialist at Bioton
BIOTON S.A.
3-2011 - 2-2020
Regulatory Affairs Specialist at Gedeon Richter Polska
Gedeon Richter Polska
5-2010 - 3-2011
Pharmacist
Apteki Pod Lipą Sp. z o.o., Komornicka 4, Tarczyn
In the press

Media appearances

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Education
2019 - 2021
Master of Business Administration - MBA
SGH Warsaw School of Economics
2004 - 2010
Master of Science (M.Sc.)
Medical University of Warsaw - MUW
Social presence
in
Behavioral profile

DISC profile (public)

DISC behavioral profile

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