Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Material Sciences Expert

7 days ago

Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time
Job Description

Takeda is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a Senior Director and Regulatory Platform Lead to join our team in Cambridge, MA.

Key Responsibilities
  • Develop and implement innovative regulatory strategies for device and combination products, with a focus on Material Sciences.
  • Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Material Sciences.
  • 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.
  • Lead regulatory strategy, briefing book authoring and meetings with global health authorities.
  • Review and approve medical device development design control documentation, including technology transfer protocols, design verification and validation protocols and reports, technical reports, Material Sciences protocols and reports, etc., to assure alignment with regulatory requirements and standards.
  • Proactively identify combination product and device-related regulatory risks, ensuring timely communication with line management.
  • Support and/or lead assigned device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.).
  • Provide global regulatory input and support on product-compliance related activities including, change controls, deviations, and investigations.
  • Work 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.
Requirements
  • 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 plus.
  • Experience 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 success.
  • Proven expertise and experience in the area of Material Sciences and allied fields for drug-device combinations.
  • Experience 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 regulators.
  • 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.
  • Active participation in industry forums is expected.
  • 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, with an emphasis on Design Control issues.
  • A minimum of 10 years of relevant industry experience (e.g., combination of pharmaceutical and medical devices). 2 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.

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