Technical Regulatory Advisor, Drug-Device Combinations - CMC Global Regulatory Affairs

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 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 preferred
• 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for device and drug-device combination products in US
• 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 leading/supporting interactions with health authorities 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 US
• 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