Brussels Metropolitan Area
• Proactive Regulatory Affairs professional with 8+ years of experience in regulatory, including knowledge of INDs/CTAs management for global, multiphase studies, experience preparing global Health Authority (HA) Meetings, and post‐approval/lifecycle management. • Collaborative professional exhibiting strong communication, planning, and organizational skills crucial for successfully managing multiple projects. Experience interfacing cross‐functionally with various internal/external stakeholders to complete objectives. • Pharmaceutical background bringing clinical and technical scientific knowledge and understanding as well as patient care skills
Regulatory Program Lead – Allogeneic portfolio o RA representative on Program Team meeting providing clear RA guidance and advice to all involved stakeholders. o IND/CTA submission coordination and management ensuring positive Agencies’ interactions o Leading coordination of response following Information Request and/or Ground for Non- Acceptance o Preparation and coordination of meeting with Competent Authorities Regulatory CMC Lead – global portfolio (autologous and allogeneic) o Providing global regulatory CMC expertise for product development and product lifecycle o Development and harmonisation of CMC regulatory documentation (CTD, eCTD) compliant with current guidelines. o Review and assessment of Chance Control Request o Coordination and management of major CMC amendments o Interpretation of international CMC regulatory guidelines to develop global CMC regulatory strategy and risk-mitigation plan. Major achievement: o Successful leadership and effective management of complex and dynamic projects (2 IND/CTA and several CMC major changes) to meet aggressive milestones. o Improving Regulatory/Quality excellence by implementing review planning procedure including different rounds of review and levels of review, development of CMC documentation effectivity tracking.
o Develop and manage planning strategy for Regulatory activities (i.e. consultation, initial filing) based on overall project and milestones o Provide support in compiling/writing briefing documents for US consultation (Pre-IND) o Provide support in compiling/writing for relevant internal documents o Manage IND module 3 sections activities with key stakeholders to ensure successful completion by deadlines o Compile and track source documentation Regulatory IND/CTA submission o Manage WHO prequalification dossier compilation in collaboration with key stakeholders for new multidose vaccine presentation o Manage International registration of new multidose vaccine presentation by keeping close collaboration with LOCs to evaluate registration strategy and specific requirements to ensure in a timely manner successful approval.
o Represented Regulatory Affairs on a cross-functional team for two Clinical Phase 2 Programs o Collaboration on writing Regulatory documents for a new sBLA, Orphan Drug Designation and Breakthrough designation request. o Coordinated multiple IND submissions e.g. Investigators documentation, protocol amendments. o Managed processes and projects involving multifunctional teams and/or Regulatory team to ensure successful completion by deadlines o Managed minutes writing during FDA meetings