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Stephen O'Rourke,
BSc (Hon), MSc (Med Sci)
Regulatory Affairs & Compliance
Professional experience
Nov. 2022 - today
Management Consultant 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
I have vast experience in all areas of biotech regulatory affairs. To give an introduction to some of my work in that area: As the Regulatory Affairs & Compliance Lead at Mushlabs GmbH, a biotech company focused on sustainable food production, I built and led the department, helped establish the Quality Management Team, and served on the Management and Go To Market Strategic Teams.
I also hired and trained a Regulatory Affairs intern, drafted documents and dossiers for regulatory submissions in various countries, including submitting the company's first ever Novel Food Application, coordinated external consultants, and communicated with regulatory authorities around the world.
In addition, I attended expert meetings and conferences, compiled and managed regulatory information for other departments, and evaluated the global regulatory environment. I was also responsible for managing the regulatory budget and overseeing new registration timelines and requirements.
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.