EU Regulatory Director: Lead Submissions & Access Strategy

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

Job summary

Takeda Pharmaceutical Co. in Zurich, Switzerland, seeks a Senior EU Regulatory Lead GI&I, Director, to define regional regulatory strategies and lead submissions for development and lifecycle management.

The role requires extensive regulatory experience and strong leadership across cross-functional teams. The successful candidate will coordinate with local heads, global regulatory teams, and health authorities to ensure compliant and timely approvals, while supporting market access initiatives

Qualifications

• A minimum of 10 years of experience in drug regulatory affairs, preferably EU/GEM region.
• Fluency in English is required.
• Experience with advanced therapeutic medical products (cell & gene therapy) is advantageous.
• Solid regulatory experience across development and lifecycle, including interaction with Health Authorities.

Responsibilities

• Defines and leads regional regulatory strategies to maximize regulatory success.
• Communicates submission plans and timelines to programs and leadership.
• Leads the Submission Working Group and regional regulatory meetings.
• Provides strategic regulatory guidance for development, registration and lifecycle management.

Skills

English fluency

Regulatory leadership

Regulatory strategy

Education

BSc. advanced scientific degree

BA accepted based on experience

Job description

Takeda Pharmaceutical Co. in Zurich, Switzerland, seeks a Senior EU Regulatory Lead GI&I, Director, to define regional regulatory strategies and lead submissions for development and lifecycle management.

The role requires extensive regulatory experience and strong leadership across cross-functional teams. The successful candidate will coordinate with local heads, global regulatory teams, and health authorities to ensure compliant and timely approvals, while supporting market access initiatives