21.10.2025 aktualisiert
verifiziert
Premiumkunde
100 % verfügbarManagement Consultant, Project Management
Graz, Österreich
Weltweit
Law degree from University of ViennaSkills
ISO 9000ComplianceDokumentenerstellungPharmakovigilanzECTDEtikettierungProjektmanagementPharmazieQualitätsmanagementRegulatorischen AnforderungenSoftware SystemsKlinische EntwicklungRegulatorische EntwicklungenMedizinsches MaterialTrackwiseRegulatory AffairsSicherheitsbestimmungenRisikomanagement
Regulatory Affairs
Extensive expertise in pharmaceutical regulatory affairs including submission strategies, document preparation, and compliance with EU and international regulations.
Pharmacovigilance
Comprehensive knowledge of pharmacovigilance systems, safety reporting, and risk management for pharmaceutical products across multiple markets.
Quality Management
TUEV-Certification in Quality Management (ISO 9001) with experience in implementing and maintaining quality systems for pharmaceutical operations.
Project Management
Management of complex regulatory submissions and clinical development projects with attention to timelines, resources, and compliance requirements.
IT Systems Proficiency
Experience with multiple pharmaceutical industry software systems including eCTD-Manager, Trackwise, Veeva Vault, MyAlice, TVT, DocuBridge, DocNet, and Liquent Insight.
International Regulatory Strategy
Development and implementation of regulatory strategies across EU, Eastern Europe, Middle East, Asia, North America, and Latin America markets.
Medical Device Regulations
Knowledge of medical device regulatory requirements including labeling, documentation, and transition from MDD to MDR.
Extensive expertise in pharmaceutical regulatory affairs including submission strategies, document preparation, and compliance with EU and international regulations.
Pharmacovigilance
Comprehensive knowledge of pharmacovigilance systems, safety reporting, and risk management for pharmaceutical products across multiple markets.
Quality Management
TUEV-Certification in Quality Management (ISO 9001) with experience in implementing and maintaining quality systems for pharmaceutical operations.
Project Management
Management of complex regulatory submissions and clinical development projects with attention to timelines, resources, and compliance requirements.
IT Systems Proficiency
Experience with multiple pharmaceutical industry software systems including eCTD-Manager, Trackwise, Veeva Vault, MyAlice, TVT, DocuBridge, DocNet, and Liquent Insight.
International Regulatory Strategy
Development and implementation of regulatory strategies across EU, Eastern Europe, Middle East, Asia, North America, and Latin America markets.
Medical Device Regulations
Knowledge of medical device regulatory requirements including labeling, documentation, and transition from MDD to MDR.
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischgut
Projekthistorie
Providing expertise in Regulatory Affairs, Pharmacovigilance, and Change Management for pharmaceutical and medical device companies. Managing teams of up to 60 employees with focus on regulatory submissions and compliance.
Member of management board and global QPPV, responsible for regulatory strategy, submissions, and pharmacovigilance for generic medicinal products across multiple therapeutic areas and international markets.
Taught European and US Drug Law in Bachelor program and Development and Approval of Generics in Master program for Regulatory Affairs.