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Job Description

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.

How you will contribute:

OBJECTIVES:

• Responsible for the development and implementation of innovative integral combination product regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned asset programs in EU and Global Markets
• For EU and Global Markets, utilizes technical knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management
• Builds and manages strong working relationships through active partnering with key internal and external stakeholders

ACCOUNTABILITIES:

• Responsible for demonstrating Takeda leadership behaviors
• Serves as Drug-Device Combinations EU & Global Markets lead for assigned asset programs
• In consultation with regulatory Foundational Subject Matter Expert/Platform Leads (e.g., Design Control, Human Factors, etc.), reviews design control documentation, including technology transfer protocols, design verification and validation protocols and reports, technical reports, human factors protocols and reports, etc., to assure alignment with regulatory requirements and standards
• Provides program, level tactical regulatory guidance to product teams in line with EU & Global Markets regulatory strategies and serves as device (constituent) lead for EU & Global Markets post approval regulatory assessments, excluding Japan and China
• Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
• Supports and/ or leads assigned drug-device combination aspects of EU & Global Markets regulatory submissions (e.g., IMPDs, MAAs, Variations, Technical Files, Notified Body Opinions, CE marking, etc.)
• Provides EU & Global Markets regulatory input and support on product-compliance related activities including change controls, and consults with Foundational Subject Matter Expert/Platform Leads on deviations and investigations
• Works effectively across a complex matrix environment in GRA with GRLs, GRA CMC project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target
• Develops and maintains constructive relations with key internal and external colleagues.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline.
• 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products in EU & Global Markets
• Experience working on cross-functional submission teams
• Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration and post-market support
• Experience supporting interactions with EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., CTA, IMPD, MAA and other marketing applications, post approval applications, Notified Body Opinions, CE marking, Technical File submissions, etc.) is strongly preferred
• Demonstrates emerging leadership, problem-solving ability, flexibility and teamwork
• Exercise good judgement in elevating and communicating actual or potential issues to line management
• Excellent written and oral communication skills are required, with cross-organization stakeholder engagement
• Ability to self-direct within a project team and properly manage tasks and work expectations, lead, be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy for EU & Global Markets
• Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or events, including overnight trips. Some international travel may be required.
• Requires approximately 10% travel

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