Manager, International Clinical Trial Regulatory Lead
Takeda
Zurich, Switzerland
Clinical trial applications (ctas)
Eucan and gem regions
Eu clinical trial information system (ctis)
Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada (EUCAN) and Growth & Emerging Markets (GEM) regions
Job Summary
Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada (EUCAN) and Growth & Emerging Markets (GEM) regions.
Executes or oversees all activities related to the creation, submission, management of Requests for Information (RFI) and maintenance of CTAs Globally (GEM and EUCAN region) in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes.
Ensures accurate and timely submissions and proactive communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.).
Matching Summary
Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada (EUCAN) and Growth & Emerging Markets (GEM) regions.
Skills & Requirements
Must-have
Clinical Trial Applications (CTAs)
EUCAN and GEM regions
EU Clinical Trial Information System (CTIS)
Health authority interactions
Regulatory strategy development
Submission lifecycle management
Nice-to-have
Promotes an inclusive culture
Expresses empathy for others
Self-aware and energetic
Adapts to changing circumstances
Builds and maintains relationships
Key Requirements
Minimum of 3 years of experience in drug regulatory affairs