Beatrice is Director Regulatory Affairs & Quality Assurance at SFL.
She is a sophisticated Regulatory Affairs executive, with proven ability to develop and implement global regulatory strategies for pharmaceutical and medical device companies. Beatrice’s in-depth expertise in managing EU and US approval processes, establishing and supervising high performing teams of regulatory affairs professionals, and aligning corporate processes with national health authority directives make her a valuable addition to our team. Abilities embedded in her repertoire include achieving worldwide regulatory compliance, gaining fast-track approvals, and ensuring timely product launches. She was actively involved in representing industry interests on various topics, such as advanced therapy medicinal products, in several working groups at EBE and EFPIA.
She has extensive experience in senior level negotiations with regulators, including review and assessment of the impact of legislative changes in the EU, US and several Asian countries. In addition, she has an excellent understanding in developing interaction strategies with various stakeholders, such as the European Commission, European and national regulators, and think tanks.
Beatrice currently leads several global early development projects providing strategic and operational guidance for clients developing drugs and medical devices, as well as acting as a regulatory coach for start-up companies
Prior to joining SFL, Beatrice held various leadership positions in the pharmaceutical industry. She also served as global Head of Regulatory Affairs in the medical device field.
She received her PhD in genetic Microbiology from the University of Freiburg, Germany.
Regulatory Affairs & Quality Assurance
SFL Regulatory Affairs & Scientific Communication Ltd.