Susanne Burek

18 years of broad expertise in EU and Global Drug RAM (CMC/Labelling/Administrative) RAM: Strategy MAA LCM Post Approval Activities Compliance Change Control Submission Management CTD Update PV: Literature Screening Case Processing Signal Management MedDRA Coding COUNTRIES: EU CEFTA APAC MENA LATAM OCEANIA IT: DMS RIMS SharePoint ARISg EudraVigilance SKILLS: strong business analysis skills High level of social and interpersonel skills PROJECT LIST ON DEMAND www.freelance.de/Freiberufler/85489

MA Maintenance CMC, Change Control, Life-Cycle-Management, XEVMPD, CCDS-Update, Execution of Global Product Recall, Referral-Procedures, tight collaboration with Manufacturer, Pharmacovigilance, Quality Assurance, Publishing Team, Labeling Team; Supported Countries: - entire EU - Switzerland - Ukraine - CIS-Countries - Turkey - Korea - China - Mexico - Venezuela

Focus: - European MA - New Registrations and Repeat Use Procedures - Variations - Renewals - Creation of a Knowledge Management WIKI Products: - Phytopharmaca - Traditional Drugs - Vitamines - Minerals

- Management of special permissions in line with §3(2) BtMG for medically-supervised self-treatment with medicinal cannabis - Management of special permissions for clinical trials on narcotics

Employment exchange, recruitment agency, employer service, coaching of young and older unemployed academic clients, issuing of work permits, placement of job advertisements, holding of job interviews, field visits to employers, data collection and analysis, acquisition

R&D, High Throughput Screening (HTS), signaltransduction, molekularbiology, cellbiology, performance of human gene cloning, vector construction and data evaluation with DNA-Analysis-Software, clone pool analysis, pharmakological characterisation of cell lines using reporter genes

Molekularbiological Reserch on Receptor-Tyrosin-Kinases; Pattern Formation, Signaltransduction; Developmental Biology

Molecular Biology, Biochemistry, Zoology, Botany, Palaeontology