Associate Director, EU Regulatory Lead Neuroscience

Takeda Pharma AG seeks an Associate Director to lead EU regulatory strategies for neuroscience assets in Zurich, ensuring successful development and market access.

The company is looking for a leader to define and execute regional regulatory strategies for neuroscience products. This role involves guiding cross-functional teams through the European regulatory landscape to secure approvals and manage product lifecycles effectively.

Responsibilities

• Create and implement forward-thinking EU regulatory plans for neuroscience assets throughout their development and lifecycle.
• Oversee regional regulatory submissions to ensure high-quality execution and timely approvals.
• Offer strategic and tactical regulatory advice to global and regional project teams.
• Head Submission Working Groups and act as the EU representative on global regulatory teams.
• Manage interactions with European and national Health Authorities, including meeting preparation and outcome communication.
• Monitor emerging regulatory trends and translate them into proactive strategies.
• Provide regulatory expertise across drug development, registration, and post-marketing activities.
• Assist the value and access team with Health Technology Assessment interactions when needed.
• Foster strong relationships with local and global Regulatory Affairs teams, partners, and authorities.

Requirements

• Bachelor’s degree in a scientific field.
• At least 8 years of experience in drug regulatory affairs, with significant EU region experience preferred.
• Deep understanding of EU regulatory requirements across all drug development phases.
• Proven track record in developing and executing regulatory strategies for timely approvals.
• Experience with investigational submissions, including clinical trial applications, orphan designations, and Marketing Authorisation Applications.
• Experience leading or participating in Health Authority interactions.
• Strong strategic thinking to assess regulatory risks and opportunities.
• Excellent communication and stakeholder management skills.
• Fluent English proficiency.
• Ability to work independently in complex environments.
• Willingness to travel internationally as required.

Nice to have

• Advanced scientific degree.
• Knowledge of regulatory requirements in other global regions, such as the US or emerging markets.