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 USFor 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 managementMonitors regulatory landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidanceInfluences 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 productsBuilds and manages strong working relationships through active partnering with key internal and external stakeholdersCombines 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 behaviorsServes as Drug-Device Combinations US lead for assigned asset programsIn 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 standardsProvides 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 assessmentsProactively identifies combination product and device-related regulatory risks, ensuring timely communication with line managementSupports 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 investigationsWorks 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 targetDevelops 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, higher degree preferred10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for device and drug-device combination products in USExperience working on cross-functional submission teamsSolid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration and post-market supportExperience leading/supporting interactions with health authorities is strongly preferredDemonstrates 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 strategy for USAble 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