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Stephen O'Rourke,
BSc (Hon), MSc (Med Sci)
Regulatory Affairs & Compliance
Professional experience
Nov. 2022 - today
Management Consultant / Senior Expert Manager in Regulatory, Risk, & Compliance
Sept. 2021 - Oct. 2022
Regulatory Affairs & Compliance Lead
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 (incl. Data Protection Officer)
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 last role as Global Regulatory Affairs & Compliance Lead I was tasked with building and leading the Regulatory Affairs department. In this role I successfully drafted and submitted the company's first ever Novel Food Application in Europe and applications in other territories. 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
Analytical and solution-oriented scientist using my personal and professional experiences to solve problems.
• 10+ years of professional experience gained at various biotechs in a variety of roles:
Application Scientist, Research Scientist, Marketing Manager, Data Protection Officer, Regulatory Affairs Manager / Lead.
• 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., and on the Board of the RunningHome.ie worldwide campaign, raising funds to support our homeless friends in our society.
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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Disclaimer: The views expressed on this website are exclusively personal, and do not necessarily reflect views, positions, or policies of my current employer.
© Stephen O'Rourke. All rights reserved.