Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Human Factors

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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:

• Leadership in for the development and implementation of innovative pure device and combination product regulatory strategies particularly pertaining to the development, registration, commercialization and life cycle management with a focus on Human Factors, ensuring that 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, with emphasis on Human Factors, and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
• Globally influences and serves as a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry on Human Factors
• Influences changing regulations and guidance documents; and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy of Human Factors
• Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives on drug-device combination and allied filings

ACCOUNTABILITIES:

• Responsible for demonstrating Takeda leadership behaviors
• Acts as Foundational Subject Matter Expert/Platform Lead within Takeda on the topic of global regulation pertaining to Human Factors for devices and combination products
• Provides tactical regulatory guidance on Human Factors to product teams in line with global regulatory strategies
• Develops strategies, tools and trainings to develop the combination product regulatory team on Human Factors
• Authors, reviews, provides critical assessments and gives input on drug-device combination regulatory strategies in regulatory filings through clinical development and commercial product lifecycle
• Lead regulatory strategy, briefing book authoring and meetings with global health authorities
• Reviews and approves medical device development 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
• Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
• Supports and/ or leads assigned device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
• Provides global 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, CMC RA 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
• Evaluate new business development opportunities or participate on due diligence teams.
• Develops and maintains constructive relations with key internal and external stakeholders.
• Develops CMC Device & Combination product staff on the subje