Anne-Valérie ANGERARD

Anne-Valérie began her career in preclinical pharmacokinetics at Hoffmann-La Roche in Basel, before specializing in regulatory affairs. She first held a position at Galderma headquarters, where she was responsible for regulatory affairs for North America and Latin America. She then joined the laboratory Aguettant, where over 15 years she held both operational and managerial roles in regulatory affairs.

Initially, she managed a product portfolio, handling the preparation of registration dossiers (Modules 1 to 3), submitting them in Europe and internationally, as well as all life-cycle management activities (variations, renewals). Subsequently, she was appointed Head of the Europe Registration Team, contributing for 5 years to the registration of many products at the European level.

She finally held the position of Head of Regulatory Affairs for the Anesthesia-Resuscitation range, where she led for 5 years the registration strategy for the European, U.S., and Canadian markets. In this capacity, she was actively involved in several complex registration procedures, including a referral procedure and Break-Out Sessions. She also contributed to defining the regulatory strategy for combination drugs.

With more than 15 years of experience in regulatory affairs, Anne-Valérie turned to consulting in 2017, an activity she has been practicing for 8 years. She works with pharmaceutical companies on a wide variety of products (orphan drugs, biosimilars, mature products, OTC…), on topics ranging from regulatory strategy to life cycle management, including product launches, switch dossiers (Rx to OTC), and adapting to regulatory changes such as the new variation regulation.

She also leads trainings designed to strengthen team skills and autonomy in the face of these European regulatory framework changes, particularly the new variation regulation.

Within ATESSIA, Anne-Valérie will lead the Regulatory Affairs sub-division, with the mission of structuring and strengthening, alongside our existing teams, our expertise in registration of health products, regulatory strategy to be proposed in the context of obtaining marketing authorizations (MA), and in managing life cycle management. Her dual perspective of industry and consulting will bring to ATESSIA expert positioning on high-stakes projects, supporting our clients in defining and executing their market access strategies, regulatory compliance, and optimizing their dossiers.