Berlin Metropolitan Area
- Responsibility for all activities related to regulatory processes and developing, reviewing and maintenance of regulatory high level documents - Coordination of CROs regulatory activities for Clinical Trial registration - Establishing regulatory strategies for development projects
- Lead of the regulatory team “Oncology/CNS” - Management and coordination of regulatory tasks and schedules - Regulatory consultation of development programs - Review of high-level regulatory documents - Preparation and participation of local scientific advice meetings (BfArM)
- Maintenance of CMC documentation of Erbitux (monoclonal antibody for cancer therapy) - Review and compilation of CMC documentation for license applications, variations and clinical study applications - Contact person for CMOs - Regulatory consultant for development projects