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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 end-to-end management including liaising, coordinating, providing oversight for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners
• Utilizes regulatory strategy and/or operational expertise and 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 primary Global Regulatory Affairs CMC Device and Drug-Device Combinations contact for sourcing partners on select programs and cross-program work.  This includes but is not limited to compliance/maintenance roles on the device (constituent) such as annual reports, renewals, relevant health authority listings, procurement of documentation (legalization, declaration of conformity, other certificates, etc.)
• Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
• Supports as needed, assigned work on drug-device combination aspects of regulatory submissions (e.g., CTAs, registrations, Variations, Technical Files, Notified Body Opinions, CE marking, etc.) in collaboration with sourcing partners
• Serves as point of contact for support from sourcing partners on audits and investigations
• 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
• 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, 510(k), Notified Body Opinions, 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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