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Job Description

About the role:

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 in order to bring life-changing therapies to patients worldwide.

How you will contribute:

• Provides operational oversight to the activities related to regulatory information management data and system maintenance, guiding the team through challenges and aligning with the overall business strategy.

• Contributes to the development, implementation, and governance of RIM system enhancements, identifying innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap.

• Promotes regulatory information quality, reporting, and development and monitoring of KPIs to ensure quality.

• Develops, in coordination with Head of RIM, continuous improvement of existing RIM processes and KPIs.

• Supports effective migration of Regulatory Information resulting from M&A and Integration activities.

• Works closely with cross-functional stakeholders to manage and support complex RIM and migration scenarios.

• Responsible for compliance with data standards and reporting requirements as well as necessary Health Authority interaction (e.g., XEVMPD, IDMP), while working proactively to identify and mitigate any risks or gaps in data and regulatory strategy.

• Responsible for supporting Regulatory components of PSMF reporting, adapting strategies based on evolving global regulatory landscape.

• Acts as a primary source for business RIM system and process support, fostering transparency and collaboration across teams.

• In coordination with Head of RIM, provides leadership and direction to external partners and vendors on regulatory specifications for information management, aligning with Takeda’s and Health Authority expectations, ensuring flawless execution.

• Manages and drives Regulatory information management projects across the business

• In coordination with Head of RIM, Manages and drives Regulatory information management projects across the business, seeking input from diverse stakeholders to drive innovative solutions and ensure timely execution.

• Stays up to date on agency-related expectations for information management projects (e.g., IDMP, xEVMPD), identifying potential risks and providing creative mitigation steps.

• Manages and oversees vendor(s) in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships.

• Supports the development of procedure documents and best practices for RIM, ensuring these are aligned with industry standards and Takeda’s internal guidelines.

• Provides independent leadership and direction on regulatory specifications for RIM systems, working closely with cross-functional teams to achieve shared goals.

• Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing challenges that arise during development and commercialization.

• Involves team members and stakeholders in the decision-making process, clearly communicates objectives, engages in brainstorming with team members and stakeholders to identify ways to move project/task forward