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 timeMaintain 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 FactorsInfluences changing regulations and guidance documents; and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy of Human FactorsEstablish 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 behaviorsActs as Foundational Subject Matter Expert/Platform Lead within Takeda on the topic of global regulation pertaining to Human Factors for devices and combination productsProvides tactical regulatory guidance on Human Factors to product teams in line with global regulatory strategiesDevelops strategies, tools and trainings to develop the combination product regulatory team on Human FactorsAuthors, reviews, provides critical assessments and gives input on drug-device combination regulatory strategies in regulatory filings through clinical development and commercial product lifecycleLead regulatory strategy, briefing book authoring and meetings with global health authoritiesReviews 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 standardsProactively identifies combination product and device-related regulatory risks, ensuring timely communication with line managementSupports 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 investigationsWorks 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 targetEvaluate 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 subject of Human Factors 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, Advanced Degree Preferred.10+ years of experience in a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience is a plusExperience working on cross-functional teams including technical quality and commercial manufacturing and supply stakeholders, leading and influencing on regulatory positions, to set programs on course for regulatory successProven expertise and experience in the area of Human Factors and allied fields for drug-device combinationsExperience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.)
is strongly preferred, including expertise with proposing science-based, data-driven regulatory positions and conducting negotiations with regulatorsDemonstrates emerging leadership, problem-solving ability, flexibility and teamworkExercise good judgement in elevating and communicating actual or potential issues to line managementExcellent written and oral communication skills are required, with cross-organization stakeholder engagementAbility 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 strategyActive participation in industry forums is expectedAble 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, with an emphasis on Design Control issues2 years management of direct reports desired TRAVEL REQUIREMENTS: Willingness to travel to various meetings or events, including overnight trips.
Some international travel may be required.Requires approximately 10% travel