EU Regulatory Lead & Strategy Director, GI&I

Takeda; Zürich; On-site; CHF 177,000 - 244,000; Full time

Job summary

Takeda, Zurich, Switzerland, seeks a Senior EU Regulatory Lead GI&I, Director, to drive regional regulatory strategies and submissions across the EU. You will lead the team, coordinate with global regulators, and support patient access initiatives with a strategic, proactive approach.

The role requires 10+ years in regulatory affairs, strong English communication, and leadership abilities to mentor staff and influence project outcomes. Based in Zurich with full-time duties.

Qualifications

• 10+ years of experience in drug regulatory affairs.
• Regulatory experience across EU regions and product life-cycle.
• Experience with cell & gene therapy is advantageous.
• Fluency in English.
• Strong leadership and collaboration skills.

Responsibilities

• Define regional regulatory strategies aligned with management.
• Lead submission plans and timelines for regulatory approvals.
• Act as deputy Regional TA Team Lead when needed.
• Lead the Submission Working Group and regional health authority interactions.
• Provide strategic guidance and mentoring to team members.

Skills

English fluency

EU regulatory experience

Regulatory affairs

Leadership

Education

BSc/BA in science

Job description

Takeda, Zurich, Switzerland, seeks a Senior EU Regulatory Lead GI&I, Director, to drive regional regulatory strategies and submissions across the EU. You will lead the team, coordinate with global regulators, and support patient access initiatives with a strategic, proactive approach.

The role requires 10+ years in regulatory affairs, strong English communication, and leadership abilities to mentor staff and influence project outcomes. Based in Zurich with full-time duties.