Welcome to RegSmart, Sinéad Breen, senior consultant

In September, you joined the RegSmart team as senior consultant medical device and pharmaceuticals.

What is your background, prior to joining RegSmart?

Since qualifying as a Pharmacist many years ago the main focus of my career has been within the Pharmaceutical and MedTech industry. Beginning with joint QA/RA roles I subsequently focused on Global Regulatory Affairs Roles for the last 20 years.

During this time I have worked with a number of start-ups as well as Big Pharma companies and come most recently from a role as Head of Regulatory Affairs with Galderma, heading up the team responsible for Galdermas Medical Device portfolio. This was a Global role with responsibility for Global Regulatory Strategies in order to optimise time to approval and market. I have worked with new registration applications and regulatory maintenance across most countries in the world and have therefore extensive knowledge and experience of US, China, European and other regulatory affairs environments. Being part of a big Global organisation, I have worked extensively with matching the company commercial strategies with the reality of Regulatory constraints. 

What are your strengths? How do you contribute?

Besides my technical knowledge of Regulatory Affairs at Global level, I would say my main strength lies in my ability to see things from a strategic perspective.  Even if this sounds a bit of a cliché, I always try to see the bigger picture and handle potential problems with that end in mind. Being a critical thinker, I have good skills in negotiating complex discussions always looking for the best outcome in every situation. I am also a people person and thrive on personal interaction and teamwork! These particular strengths have been useful and beneficial both to me and the companies I have worked with, in my interaction with National Medical Authorities and Notified Bodies, including many face to face meetings with the US FDA, Chinese FDA etc.

What are you looking forward to at RegSmart?

I am really looking forward to working with the talented team at RegSmart and to be able to provide valuable regulatory and strategic input to new and existing projects. I hope that with my long experience, I can provide some new insights to the team and I also look forward to learning from them. I hope that through the interaction with so many diverse and talented colleagues and customers that my own experience can be both shared and incremented in a social and professional environment.


 “Sinéad adds the global regulatory affairs knowledge, within medical device as well as the pharmaceutical field. That, combined with the strategic and commercial perspective brings a great contribution to the RegSmart team. Most welcome, Sinéad!” says Mats Högberg, Director medical device and IVD, RegSmart.