Regulatory Affairs Project Manager(m/w/x)

Description

You will drive global product access by navigating complex regulatory landscapes, transforming intricate requirements into strategic dossiers while fostering cross-functional innovation.

Requirements

• •Degree in Life Science, Data Science, or comparable qualification
• •Minimum 5 years professional experience in relevant environments
• •Foundational experience in Healthcare Regulatory Affairs
• •Understanding of global regulatory landscape
• •Track Record in IVD or Pharma Regulatory (plus)
• •Experience managing high-complexity workflows or global projects
• •Ability to work independently and drive results
• •Business fluent English skills
• •Ability to interpret regulatory frameworks
• •Self-motivated problem solver with compliance focus
• •Bachelor- oder Master-Abschluss oder vergleichbare Qualifikation
• •Mindestens 5 Jahre Berufserfahrung im relevanten Umfeld
• •Fundierte Erfahrung in Regulatory Affairs im Gesundheitswesen
• •Verständnis für globale regulatorische Umfelder
• •Erfahrung in der Verwaltung hochkomplexer Arbeitsabläufe
• •Verhandlungssichere Englischkenntnisse
• •Fähigkeit zur Interpretation regulatorischer Rahmenbedingungen

Tasks

• •Lead product approvals and lifecycle management
• •Coordinate strategic cross-functional collaboration
• •Ensure timely delivery of submission-ready documentation
• •Maintain global regulatory compliance
• •Develop and oversee complex submission dossiers
• •Execute accurate global product registrations
• •Share experience to enhance team expertise
• •Design innovative strategies for product access
• •Build relationships with internal and external stakeholders
• •Integrate regulatory needs into company strategy
• •Foster an inclusive environment using VACC principles
• •Troubleshoot issues and implement cost-effective solutions

Tools & Technologies