Zurich, Switzerland
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
Responsible for regulatory aspects of biosimilar ranibizumab (RANIVISIO) ● Submissions in new markets and management of global regulatory product life cycle ● Define submission strategy and planning within cross-functional brand teams in alignment with customers ● Lead local RA team ● Support Bioeq AG in all aspects related to Regulatory Affairs
Product Lead Biosimilar ranibizumab (RANIVISIO) ● Managed global regulatory product life cycle ● Prepared submissions for new markets together with international cross-functional team ● Maintained the Quality System for Regulatory Activities ● Ensured compliance of regulatory procedures and records with respect to CMC / Quality
Product Lead Oral Iron portfolio managing global RA-LCM activities. ● Lead of RA Functional Team consisting of LCM, CMC, Labeling, Submissions, Reg Ops. ● RA representative in Oral Iron Global Brand Team. ● Budget responsibility for global RA Oral Iron portfolio. ● On-boarding, coaching and supervision of a team of 3 remote co-workers. ● Close interactions with affiliates and partners to align submission strategy and planning. ● Key contributor to data migration project into RIMS (regulatory information management system). ● Introduced the use of cloud-based working tools allowing for collaborative authoring when cooperating with affiliates and partners.
Responsible for regulatory compliance of CMC documentation of the Oral Iron portfolio (Solida). ● Liaised with regulatory affairs functions (Therapeutic Area, Partner Business, Submissions, Reg Ops) and technical departments (Manufacturing, Supply Chain, R&D) to align submission strategy and planning. ● Prepared RA-CMC documentation for life-cycle management. ● Contributed to the harmonization of Module 3 dossier content and supported global rollout. ● Covered CMC part in deficiency letters and performed impact assessments for change control process. ● Represented RA-CMC in relevant project teams providing regulatory guidance.
Responsible for writing scientific reports for the physicochemical characterization of a NBCD, including oversight of data generation and elaboration of data evaluation strategies. ● Closely interacted with RA-CMC group, provided scientific advice and shaped the storyline while quickly adapting to changes. ● Contributed to the preparation of regulatory documents (CTD Module 3).
● Strongly improved the effectiveness of collaborations with bioanalytical vendors. These elements were key: 1) Evaluated candidates and selected top-grade CRO partner 2) Established trustful relationship. 3) Put in place an efficient monitoring system. ● Defined bioanalytical strategy (PK, ADA, Biomarkers) for clinical testing of multiple drug candidates. ● Led the bioanalytical group which is in charge of developing immunoassays in-house, outsourcing to GMP, GLP and GCP vendors and monitoring their activities. ● Closely interacted with Development Teams and provided expert advice, data overviews and planning input.
● Led global Biologics Drug Development project from the discovery through the preclinical phase including definition of project strategy, stakeholder management, analysis of competitive landscape, and advancing the project through NIBR stage-gate meetings. ● Managed the development of immunological and pharmacological assays for screening and lead selection purposes. ● Developed bioanalytical immunoassays (PK, ADA, PD) for preclinical and clinical testing of multiple drug candidates and ensured the assay transfer and validation at bioanalytical CROs. ● Managed and monitored the analysis of samples from preclinical and clinical studies at CRO labs. ● Built and successfully managed a team of three Lab Associates/Scientists. ● Participated in various leadership courses/programs offered by Novartis.
● Developed and validated immunoassays in compliance with GLP ● Managed GLP bioanalysis (PK, PD, immunogenicity) of clinical studies ● Communicated with customer as first point of contact ● Managed projects and project teams with responsibility for prioritization, timelines, quality and costs ● Actively participated in GLP audits by regulatory authorities ● Technical authority responsibilities for the Lab Associates/Scientists of the bioanalytical laboratory at Celerion