Associate Director, Senior International Clinical Trial Regulatory Lead
Takeda
Zurich, Switzerland
Fully remote
8+ years regulatory affairs experience
Eu clinical trials regulation ctr knowledge
Ctis portal submission expertise
The role involves developing regulatory strategies and operational plans for clinical trials across Europe, Canada, and emerging markets
Job Summary
The role involves developing regulatory strategies and operational plans for clinical trials across Europe, Canada, and emerging markets.
Candidates must possess deep expertise in the EU Clinical Trials Regulation (CTR) and hands-on experience with the CTIS portal.
The position requires leading cross-functional teams to ensure timely submissions while maintaining full compliance with global and regional standards.
Matching Summary
The role involves developing regulatory strategies and operational plans for clinical trials across Europe, Canada, and emerging markets.
Skills & Requirements
Must-have
8+ years regulatory affairs experience
EU Clinical Trials Regulation CTR knowledge
CTIS portal submission expertise
Team leadership and mentoring skills
Oncology and neuroscience therapeutic areas
Nice-to-have
Experience with non-EU regulatory landscapes
GxP audit proficiency
Strong cross-functional collaboration abilities
Proactive problem-solving in dynamic environments
Key Requirements
Minimum 8 years of regulatory affairs experience
Advanced scientific degree or equivalent experience