Management Team


EUDRAC is a European specialised regulatory affairs and pharmacovigilance consultancy company providing support to our clients to drive products through development, registration, market launch and post-approval activities across all EU countries.

EUDRAC is based in Germany, France, Switzerland and the UK, successfully guiding pharmaceutical and medical device companies since 2002. Our expertise covers a wide spectrum of therapeutic areas and pharmaceutical forms. Our experienced staff (majority have more than 10 years of experience) includes pharmacists, chemists, biologists, a medical doctor, and pharmacovigilance and regulatory affairs specialists. A high level of repeat business and ongoing long–term assignments with our clients is proof of our excellent service.

We are dedicated to provide “quality for success” for your projects. Let us help you to achieve your goals!


Our highly qualified and experienced management team each have more than 25 years experience in regulatory affairs.
Please see more information about our management team, below.

EUDRAC GmbH, Germany
Ute Junghanns
MSc Reg. Affairs, Pharmacist

Ute graduated as a pharmacist in 1988 from the Berlin Free University, Germany and went on to complete the BIRA/TOPRA Diploma (2000) and MSc in Regulatory Affairs (2002), both awarded with distinction. She is also qualified to act as the national German QP and EU QP for Pharmacovigilance.

Her professional career has been within Regulatory Affairs since 1989, including employment at Schering AG, Takeda and Allergan.

In 2002, Ute founded her own consultancy company, EUDRAC GmbH (European Drug Regulatory Affairs Consulting), based in Heidelberg, Germany.

Bertrand Rousse
Bioorganic Chemistry, MSc, DEA

Bertrand graduated in Bioorganic Chemistry from Nantes University in 1990. He started his career in academic research (PhD) at Uppsala University (SE) but made the move to industry more than 25 years ago.

Bertrand  joined Arkopharma where he developed his regulatory affairs skills for OTC medicines. After few years at NicOx he joined Allergan where he further developed his career in EU and in the US as RA Director for NCE. Bertrand joined Bayer Consumer Care as Head Global Regulatory CMC team in 2007.

In 2012 he made a swift move to Galderma as Head Global Regulatory Affairs for the Consumer business in Sophia Antipolis and Vevey (CH) where he was ultimately responsible for the full Consumer portfolio in more than 90 countries (OTC drugs, Cosmetics, Medical Devices, Food supplements) with a team based in France,  Switzerland, USA

In 2020, Bertrand joined EUDRAC to manage the French office of EUDRAC SARL.

Join our team

EUDRAC is not currently recruiting for positions. However, if you wish to submit an unsolicited application, please send your curriculum vitae / resume and covering letter to

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