Associate Director, Eucan Regulatory Lead - Gi And Inflammation

Takeda

Zurich, Switzerland
Fully remote
Regional regulatory strategy
Submission excellence
Health authority interactions
Lead regional regulatory strategy for assigned assets, driving submission excellence across development, registration, and life-cycle management to enable timely patient access

Job Summary

  • Lead regional regulatory strategy for assigned assets, driving submission excellence across development, registration, and life-cycle management to enable timely patient access.
  • Define and communicate regulatory strategies, submission plans, and timelines, while proactively assessing regulatory risks and the impact of evolving requirements.
  • Contribute to the development of team members and provide direction, support, mentoring, and strategic guidance to fulfil scope of project work.

Matching Summary

Lead regional regulatory strategy for assigned assets, driving submission excellence across development, registration, and life-cycle management to enable timely patient access.

Skills & Requirements

Must-have

  • Regional regulatory strategy
  • Submission excellence
  • Health authority interactions
  • Lifecycle management
  • Regulatory risk assessment

Nice-to-have

  • Proactive approach to planning
  • Develops effective working relationships
  • Promotes an inclusive culture
  • Active listening and open dialogue

Key Requirements

  • Minimum 8 years of experience in drug regulatory affairs
  • Experience in EU/GEM region
  • Knowledge of regional regulations and guidance
  • Experience leading Health Authority interactions
  • BSc or Advanced scientific degree preferred

Work Rights

Not specified

Tailored Resume

Cover Letter