Technical Regulatory Advisor, Drug-Device Combinations US

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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 device and integral/co-packaged combination product regulatory strategies for development, registration, commercialization and life cycle management of assigned asset programs in US
• For US and with a global mindset, utilizes technical combination product knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management
• Monitors regulatory landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance
• Influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in industry for US regulatory activities for devices and combination products
• Builds and manages strong working relationships through active partnering with key internal and external stakeholders
• Combines knowledge of scientific, regulatory and business issues to ensure regulatory filings are of high quality and right first time.
• Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
• Influences changing regulations and guidance documents; interfaces with regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy.

ACCOUNTABILITIES:

• Responsible for demonstrating Takeda leadership behaviors
• Serves as Drug-Device Combinations US lead for assigned asset programs
• In consultation with Platform Regulatory Subject Matter Experts, 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 US regulatory strategies and serves as device (constituent) lead for US post approval regulatory assessments
• Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
• Supports and/ or leads assigned device and drug-device combination aspects of US regulatory submissions and internal documentation (e.g., IND, NDA/BLA, postapproval filings, 510k, device master files, DHFs, etc.)
• Provides US regulatory input and support on product-compliance related activities including, change controls, 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 a