Senior Manager, EUCAN Regulatory Lead, Marketed Products

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Job Description

• Ensures regional regulatory strategies are written, reviewed and executed according to plan
• In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Manages, plans, and executes regional regulatory submissions and ensures timely approvals throughout product development and lifecycle
• Partners with the regional market access and local regulatory affairs colleagues to define the strategy for, and to oversee joint interaction with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
• Partners with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of scope
• Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on a timely manner
• In partnership with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
• Under supervision from a senior team member and/or Line Manager, represents Takeda in Health Authority meetings, as required. Effectively conveys and manages meeting outcome and next steps
• Lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products, as needed
• Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives
• Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team and /or higher governance bodies
• Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management

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