Associate Director, Senior International Clinical Trial Regulatory Lead

Takeda

Zurich, Switzerland
Fully remote
Clinical trial applications (ctas)
Eu clinical trial information system (ctis)
Regulatory strategy development
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, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes.
  • Provides strategic and tactical advice and guidance and CTA regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of assigned development programs.

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)
  • EU Clinical Trial Information System (CTIS)
  • Regulatory strategy development
  • Health authority interactions
  • CRO regulatory oversight

Nice-to-have

  • Integrity, fairness, honesty, perseverance, teamwork
  • Proactive problem-solving
  • Inclusive culture
  • External stakeholder engagement

Key Requirements

  • BSc. or Advanced scientific degree
  • 8+ years regulatory affairs experience
  • Several years team leadership experience
  • Expertise in EU clinical trial submissions
  • In-depth CTIS and CTR knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter