Stephane Andre is a seasoned, visionary and passionate leader in life sciences industry (more than 35 years) in Pharma Regulatory Affairs with a large experience in: global drug development, clinical safety, clinical development quality, labeling, acquisition of new assets through integration or alliance of partners (including small molecules, biologicals and vaccines). Main therapeutic expertise were Oncology, anti infectives, HIV, neurologic disorders, bone disease, endocrinology, vaccines. All along the years Stephane developed Global Health Authorities interactions strategies, affiliates organizations transformations, market access sequencing and regulatory challenges as complex global regulatory data collection ensuring local and corporate regulatory compliances in connection with labeling, clinical safety, manufactured batch releases. As an experienced leader stephane build up: teams with multi-cultural and cross-functional leadership, executive management of large teams, risk identification, risk management strategies, and project management.His background is scientific as a biologist trained both in cellular and molecular biology, complemented by a PhD in Toxicology and a post doc degree as veterinary Histopathologist in French Universities and Veterinary school.Stephane positions himself as a leader building bridges between teams, functions, stakeholders, companies, affiliates, authorities using his technical skills and accountabilities but also his vision to project successful interactions with internal and external key stakeholders to adapt or anticipate environmental changes, to develop sound strategies supporting marketing authorization and market introduction and to use his negotiation skills in issue management.As a Regulatory professional he interacts with worldwide Health Authorities to develop regulatory/clinical development strategies adapted to specific drugs and regions, EU, US, ASIA, LATAM, Emerging Markets. As a long standing global regulatory leader working in multi-location (EU, US, Japan, China) he has developed a rich experience and vision of current and future challenges for regulatory strategies, Clinical Trials Applications, Real World Data/Real World Evidence generation and access to patients. Stephane’s entrepreneurial spirit led him to constantly develop strong interfaces with the regional commercial organizations, to accelerate time to market but also to learn the real life experience of marketed drugs from business teams in order to provide feedback to the regulatory development teams.