Associate Director, EUCAN Regulatory Lead - GI and Inflammation

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At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life‑changing therapies to patients worldwide.

As Associate Director, EUCAN Regulatory Lead – GI and Inflammation, you will lead regional regulatory strategy for assigned assets, driving submission excellence across development, registration, and life‑cycle management to enable timely patient access. You will define and communicate regulatory strategies, submission plans, and timelines, while proactively assessing regulatory risks and the impact of evolving requirements.

• Define, develop and lead regional progressive regulatory strategies, in close alignment with line management, to maximise regulatory success and strengthen the product development plan, supporting patient access. This includes all aspects of submission and timely approval of investigational applications, market application and life‑cycle management.
• Effectively communicate the regional regulatory strategies, submission plans and timelines, assess the likelihood of success of the strategies and the impact of trends, regulations and changes related to assigned assets.
• Contribute to the development of team members and provide direction, support, mentoring, and strategic guidance to fulfil the scope of project work, when applicable.
• Provide regional tactical advice on how to achieve timely and efficient conduct of development and/or life‑cycle management of an assigned product.
• Lead the Submission Working Group and represent the region as needed on global and project teams.
• Lead interactions with health authorities in the region for an asset.
• In the EU, support the value and access team in their interactions with Health Technology Assessment (HTA) bodies for products within their responsibility.

• Demonstrate Takeda leadership behaviours and encourage the team to live up to the Takeda Code of Conduct and leadership behaviours.
• Manage, plan, and execute regional regulatory submissions in close alignment and ensure timely approvals throughout product development and lifecycle, in collaboration with regional, LOC regulatory leads, cross‑functional and global regulatory teams.
• May act as deputy to the regional therapeutic area lead and/or regional regulatory head, attending internal leadership team meetings when appropriate.
• May be regulatory lead or may support a more senior regulatory lead for assigned assets and/or projects.
• Effectively communicate the regulatory strategies, submission plans and timelines, probability of success, and impact assessments to assigned programmes and present regional regulatory strategies to leadership/senior management.
• Stay current with regulations and guidance in the region and in coordination with local regulatory leads and Global Regulatory Policy & Innovation. Provide strategic advice on emerging trends, regulations, and changes, with emphasis on those related to the assigned programme to enable proactive planning for future business needs.
• Provide regulatory expertise on drug development, registration and/or post‑marketing compliance and life‑cycle management, actively pursuing the tracking and fulfilment of post‑marketing commitments.
• May be asked to evaluate new business development opportunities and/or participate on due‑diligence teams.
• Prepare and maintain regulatory planning/filing documents for assigned products in the region.
• Participate, as appropriate, and author/review internal procedures and processes.
• Understand and interpret complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
• Su…