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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

CORE SE

Sept. 2021 - Oct. 2022

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 (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

Anton Paar GmbH (former AXO DRESDEN GmbH), Dresden

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.

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