Director - GRA Devices, Digital and Combination Products - Now Hiring

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

About the role:

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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide

Join Takeda as a Director, GRA Devices, Digital and Combination Products where you will utilize your technical combination product and device knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management.

You will also monitor the global regulatory landscape to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance As part of the Global Regulatory Affairs team you will report to the Executive Director, GRA CMC Devices, Digital and Combination Products

How you will contribute:

• Informs creation and implementation of innovative drug-device combination product and device regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products
• Acts as combination product and device regulatory expert for GRA Devices and Combination Products team, providing technical, strategic and tactical regulatory guidance to product teams
• Proactively identifies, analyzes and manages complex combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management
• Defines strategy for device-related aspects of global regulatory submissions (e.g., Technical Files, Notified Body Opinions, Core Dossiers, CTAs, INDs, MAAs, BLAs, Variations, etc.)
• Demonstrates Takeda leadership behaviors  
• 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, Labeling, etc.) to ensure comprehensive strategies are developed and project execution is on target
• Builds and manages relationships through active partnering with key internal and external stakeholders
• Represents Takeda on external regulatory consortia and standards committees to influence industry best practices, policy and standards

Minimum Requirements/Qualifications:

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 10 years of pharmaceutical Regulatory CMC and Device experience, including experience as a Device regulatory lead for drug-device combination products; international experience strongly preferred.
• Staff management experience is a plus
• Experience leading cross-functional submission teams
• Proven ability to provide strategic regulatory guidance to drug-device combination product and device development, registration, and post-market support teams
• Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (i.e., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, etc.)
• Software as a Medical Device (SaMD) / digital devices experience is a plus
• Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development and post-market support
• Able to identify, prioritize and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance
• Demonstrate leadership, problem-solving ability, flexibility and teamwork
• Exercise good judgement in elevating and communicating actual or potential issues to line management
• Active participation in external Agency/Industry groups/forums expected
• Excellent written and oral communication skills required