Brussels Metropolitan Area
Highly experienced Global Regulatory leader, who combines a thorough understanding of regulatory science, strategy, and operations, health authority interactions and labeling strategy (CCDS/SmPC/USPI) across EMA, FDA, and global markets with a knack for building open, respectful, and trust-based work environments and a passion for integrating new technologies (AI, RIM systems, e-submissions,...). Strong track record in EU regulatory pre- and post-authorisation procedures (including CMC, paediatric investigation plans, scientific advice requests, all types of variations, post-approval measures, PSURs, and more) for products approved via the EU centralised procedure. With an MSc. in Biology and a professional background spanning diverse therapeutic areas (vaccines, haematology, immuno-oncology, immunology, virology, and cardio-vascular) across all development stages for both small molecules and biologicals, I excel at building open, respectful, and trust-based work environments that allow collaborative problem-solving within fast-paced, complex environments, guiding strategic decision-making.
• Global Regulatory Strategy: Lead the execution of FDA, EMA, and RoW regulatory strategies across clinical and registrational stages, ensuring alignment with global development goals. • Team Representation: Represent the Global Regulatory Lead (GRL) in project teams and serve as the back-up EU agent for regulatory procedures. • Dossier & Strategy Management: Provide leadership on FDA, EMA, and RoW submission strategy and planning, including the management of scientific and regulatory reviews for technical dossiers. • Strategic Intelligence: Monitor regulatory and competitive intelligence to help align global submission strategies with shifting industry landscapes. • Digital & AI Subject Matter Expert: Serve as SME for AI tool integration and Regulatory Information Management best practices.
• EU Procedural Expert: Provided strategic support and tactical advice on procedural aspects of the EU Centralised Procedure (e.g., ODDs, PIPs, Scientific Advice, Variations, PSURs), including the management of scientific and regulatory reviews for technical dossiers. • EU Regulatory Strategy: Collaborated with the EU Strategy Lead across all EU procedures, acting as a delegate when necessary, and served as the dedicated delegate for the preparation and review of CMC dossiers. Managed direct contact and facilitated formal interactions with Health Authorities to ensure procedural alignment. • Compliance & Labeling Oversight: Managed labeling development (SmPC, PL) and QRD alignment, including the oversight of translation workflows and post-approval compliance. • Competitive Intelligence: Monitored shifting industry landscapes and competitive intelligence to help align global submission strategies with current EU requirements. • Systems & Digital Support: Acted as the functional representative and lead for RIMS selection and adoption, eCTD topics, and the integration of automated translation systems into regulatory processes.
See - Senior Manager, European Regulatory Procedure Strategy at Bristol-Myers Squibb
See - Senior Manager, European Regulatory Procedure Strategy at Bristol-Myers Squibb
In collaboration with Vito