Associate Director, EUCAN Regulatory Lead - GI and Inflammation

Takeda Pharma AG seeks an Associate Director to lead EUCAN regulatory strategy for GI and Inflammation assets in Zürich. The role focuses on submission excellence, authority interactions, and team mentorship.

This position is responsible for directing regional regulatory strategy for specific therapeutic assets. The role ensures timely patient access by managing submission plans, assessing regulatory risks, and guiding the product development lifecycle from registration through post-marketing compliance.

Responsibilities

• Develop and execute regional regulatory strategies to optimize product development and submission success.
• Communicate submission timelines and plans while evaluating potential risks and regulatory trends.
• Mentor team members and provide strategic guidance to support professional growth.
• Offer tactical advice to ensure efficient conduct of development and lifecycle management activities.
• Chair the Submission Working Group and represent the region on global project teams.
• Manage interactions with regional health authorities to secure timely approvals.
• Plan and execute regional regulatory submissions to meet approval deadlines.
• Present regulatory strategies and insights to senior leadership.
• Monitor regulatory changes and provide advice on emerging trends and compliance requirements.
• Prepare and maintain regulatory filing documents for assigned products.
• Lead meetings with regional regulatory bodies to discuss asset-specific issues.

Requirements

• Bachelor of Science in a scientific field; advanced degrees are preferred, though experience may substitute.
• At least 8 years of experience in drug regulatory affairs, preferably within the EU.
• Strong knowledge of regional regulations and guidance across all development phases.
• Fluent proficiency in English.

Nice to have

• Understanding of regulatory frameworks in other global regions, including the US and emerging markets.
• Experience leading or participating in interactions with health authorities.
• Background in initial marketing authorization, indication extensions, or lifecycle management submissions.

About the company

Takeda Pharma AG fosters an inclusive environment where employees are supported as whole individuals. The company encourages open dialogue, active listening, and diverse perspectives, while upholding a strong Code of Conduct and demonstrating leadership behaviors that promote ethical practices.

• Promotes an inclusive culture that supports individual well-being.
• Encourages open dialogue, feedback, and diverse opinions.
• Upholds the Takeda Code of Conduct and demonstrates leadership behaviors.