Manager, International Clinical Trial Regulatory Lead

Takeda

Zurich, Switzerland
Regulatory strategy development
Clinical trial applications management
Collaboration with cros
Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada

Job Summary

  • Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada.
  • Ensures oversight and tracking of CTA activities and eTMF updates performed by the International CTRL/CRO Regulatory Lead.
  • Works in collaboration with CRO to ensure Takeda compliance when appropriate.

Matching Summary

Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada.

Skills & Requirements

Must-have

  • Regulatory strategy development
  • Clinical trial applications management
  • Collaboration with CROs

Nice-to-have

  • Proactive problem-solving skills
  • Ability to adapt to changing circumstances
  • Empathy and inclusivity

Key Requirements

  • Minimum 3 years in drug regulatory affairs
  • Experience with EU CTR preferred
  • Fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter