Expert in drug development, including managing regulatory submissions. Broad range of experiences from over 10 years in the field in diverse environments from small biotech, to bioanalytical CRO and Big Pharma.Strong track record in leading cross-functional multi-site project teams and (pre-) clinical bioanalysis programs. With my move into the Regulatory Affairs (CMC, LCM), I further extended my experience in drug development.My collaborative, pro-active and results-driven approach together with my strong analytical thinking, high self-motivation and excellent communication and people skills allowed me to succeed in many challenging projects and to further grow in my roles. My Specialities:● Leading global therapeutic projects and cross-functional global teams● Proactive and savvy project manager ● Third party management: Foster strong personal relationships and promote productive collaboration. ● Listening to understand. Successfull negociations (Harvard concept)● Stakeholder management ● Bioanalytical assay development and validation. Subject-matter expert PK/PD and immunogenicity.● GLP-regulated bioanalytical environment, both from the CRO and the customer perspective.● Audits by regulatory authorities and by customers● Efficient approach - Sustainable solutions● Leadership, both as line manager and within matrix organization● Trilingual, German, English and French