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Stephen O'Rourke,
BSc (Hon), MSc (Med Sci)
Regulatory Affairs & Compliance
Professional experience
Sept. 2021 - Present
Regulatory Affairs & Compliance Lead
Aug. 2021 - Present
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
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!
© Stephen O'Rourke. All rights reserved.