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Stephen O'Rourke,
BSc (Hon), MSc (Med Sci)
Regulatory Affairs & Compliance

Professional experience

Sept. 2021 - Present

Regulatory Affairs & Compliance Lead

Mushlabs GmbH

Jul. 2021 - Sept. 2021

Regulatory Affairs Consultant (stephenorourke.com)

Dec. 2019 - July 2021

Regulatory Affairs Manager

Chr. Hansen HMO GmbH (former Jennewein Biotechnology GmbH), Bonn / Rheinbreitbach

Jul 2019 - Oct 2019

Marketing Manager

AYOXXA Biosystems GmbH, Cologne

Nov 2017 - Jul 2019

Commercial department / marketing roles

Ncardia AG, Cologne

Nov 2014 - Apr 2017

Research Scientist in Forensic Toxicology

Universitätsklinikum Schleswig-Holstein (UKSH), Kiel / Hamburg

Feb 2012 - Oct 2014

Application Scientist in X-ray Analysis

Anton Paar GmbH (former AXO DRESDEN GmbH), Dresden

Regulatory Affairs Experience

In my current role as Regulatory Affairs & Compliance Lead I am tasked with building and leading a department to achieve registrations of products. Prior to that I worked freelance where I provided my expertise on a pro bono basis. As Regulatory Affairs Manager I have dealt with all aspects of novel food dossiers and submissions to world-wide regulatory authorities.

  • Involvement in planning, preparation, and writing of product registrations and corresponding with
    authorities world-wide (e.g. European Commission EC; US-FDA; China Ministry of Health, etc).
  • Key role played in the submission and approval of HMO novel food product registrations to the EC / European Food Safety Authority (EFSA).
  • Attended and presented at Regulatory Affairs Meetings / Conferences.

Language skills

English

Native

Irish / Gaeilge

Advanced

German / Deutsch

Advanced

Turkish / Türkiye Türkçesi

Beginner

About me

Using my personal, voluntary, and professional experiences to solve problems.

• From Ireland; working in Germany since 2012 (Dresden, Hamburg, Cologne).
• Regulatory Affairs & Compliance Lead at Mushlabs GmbH, a biotech company using fermentation to create the next generation of sustainable foods from the roots of mushrooms (mycelium).
• Found & host of RegulatoryStory - The Regulatory Affairs Podcast, which introduces the field to a wider audience and will feature interviews with RA professionals.
• Especially enjoy working as part of multi-disciplinary teams to get projects over the finish line.
• Outside of biotech, you’ll find me playing Ireland’s ancient games Hurling & Gaelic Football with the Cologne Celtics Gaelic Sports Club e.V., where I am also Commercial & Partnership Director, and on the Boards of the German GAA / German Gaelic Games Federation and the RunningHome.ie worldwide campaign.

 

I am always interested in expanding my network and I am happy to offer my time to anyone looking for advice on their current projects / those looking to get into Regulatory Affairs. Feel free to get in touch below!

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