Manager, International Clinical Trial Regulatory Lead
Takeda UK
Zurich, Switzerland
Develop regulatory strategy for clinical trials
Manage clinical trial applications (ctas)
Oversee cta submissions and maintenance
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
Develop regulatory strategy for clinical trials
Manage clinical trial applications (CTAs)
Oversee CTA submissions and maintenance
Liaise with health authorities
Ensure Takeda compliance with CROs
Nice-to-have
Demonstrates Takeda leadership behaviors
Promotes an inclusive culture
Self-aware and energetic
Adapts to changing circumstances
Key Requirements
BSc. Advanced scientific related degree preferred
Minimum of 3 years of experience in drug regulatory affairs