Alira Health Welcomes Marie-Aude Ohresser, Vice President, Regulatory Affairs
BOSTON, USA – Alira Health, a leading international healthcare and life sciences advisory firm, announces the appointment of Marie-Aude Ohresser to Vice President, Regulatory Affairs. Based in our Basel, Switzerland office, Marie-Aude will be instrumental in bolstering our EU regulatory capabilities as well as offering more comprehensive regulatory support globally.
“We are delighted to welcome Marie-Aude to our Alira Health family. Marie-Aude joins us with a rich background and knowledge in the pharmaceutical industry including drug development, gene therapy, and various areas of regulatory affairs,” said Giacomo Basadonna, Chief Medical Officer, Alira Health. “Marie-Aude’s recruitment represents a fundamentally important step forward in expanding Alira Health’s global presence as a leading force in Regulatory Affairs for Pharma Products and Medical Devices, with the goal of transforming health care delivery for the benefit of patients around the world.”
“At this point in my career, I am ready for new challenges, and Alira Health is a perfect match for me. My new colleagues are dynamic, agile, and diligent and foster a supportive work environment,” said Marie-Aude. “I look forward to building on Alira Health’s existing pharma regulatory services as well as continuing to grow the synergies with our other divisions. I am confident that we are creating something extraordinary here, and the sky is the limit.”
Marie-Aude has over 20 years of experience in product development for the pharmaceutical industry. For the last decade, she worked with F. Hoffmann-La Roche, Ltd. as the Head of EU Liaison, Global Regulatory Affairs where she was responsible for planning and implementing strategy and activities such as optimizing resources and processes, developing KPIs, strengthening collaboration between affiliates and global regulatory departments to meet business needs. Marie-Aude has also led various cross-functional projects in the areas of regulatory records management and the pharmacovigilance system master file.
Most recently, Marie-Aude led changes related to Brexit across Roche’s pharmaceutical division. Prior to this, Marie-Aude was a regulatory strategist at Transgene SA and a project lead for a therapeutic vaccine in oncology. Marie-Aude has extensive knowledge of EU regulatory procedures and hands-on experience in preparing high-quality regulatory documentation.