Basel, Switzerland 16 October 2025
Arex Advisor are happy to welcome Regulatory Affairs Expert David Berner to the team.
David brings a strong track record in leading regulatory strategies and marketing authorisation applications (MAAs) for the EU and Switzerland. He provided critical support for multiple successful filings, amongst others for oncology products, orphan medicinal products and Advanced Therapy Medicinal Products (ATMPs). His expertise spans the entire product lifecycle – from early development, pediatric investigation plans and orphan drug designation (ODD) applications to fast-track requests, pre-submission meetings, initial MAA submissions, and post-approval activities. David is also well-versed in managing post-approval lifecycle projects across the EU, Switzerland, and the UK.
David holds a PhD in Neurobiology and an MSc in Molecular Biology from the University of Basel.
” It is a pleasure to welcome David to our team. His expertise and skills will help our clients navigate regulatory complexity with successful outcomes, particularly in high-stakes areas such as marketing authorisation applications, orphan drug development and advanced therapies.”
Linda Thunell, CEO Arex Advisor
He joins Arex Advisor from a previous role as Director Regulatory Affairs at SFL Regulatory Affairs & Scientific Communication GmbH/Veristat.
David starts his position on 16 October and will be based in Basel, Switzerland.
About us: Arex Advisor offers strategic advice and operational support for the Life Science industry. Our mission is to help leaders and companies realise projects and reach goals. We are your partner for successfully entering and navigating the EU, UK and Swiss markets. At Arex, we are passionate about successful processes, from development to commercialisation of important medicines – ultimately contributing to improving the lives of patients.
Contact:
Anja Bührer, General Manager Arex Advisor AG