Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Sciences Expert
4 days ago
We are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. This role will be responsible for leading the development and implementation of innovative regulatory strategies for CMC, Device and Drug-Device Combinations Material Sciences.
Key Responsibilities- Develop and implement regulatory strategies for CMC, Device and Drug-Device Combinations Material Sciences, ensuring compliance with relevant guidelines and regulations.
- Provide expert guidance on Material Sciences to product teams, ensuring alignment with global regulatory strategies.
- Collaborate with cross-functional teams to develop and implement strategies, tools, and trainings to develop the combination product regulatory team on Material Sciences.
- Author, review, and provide critical assessments of drug-device combination regulatory strategies in regulatory filings through clinical development and commercial product lifecycle.
- 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.
- Evaluate new business development opportunities or participate on due diligence teams.
- Develop and maintain constructive relations with key internal and external stakeholders.
- Develop CMC Device & Combination product staff on the subject of Material Sciences.
- 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 judgment 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.
- 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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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda is seeking a Senior Director and Regulatory Platform Lead for CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for pure device and combination product submissions, with a focus on...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda Pharmaceutical is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda 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 ResponsibilitiesDevelop and implement innovative regulatory strategies for device and combination...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products, with a focus on Material...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda Pharmaceutical is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for CMC and device-drug combinations.Key...
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Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team in Cambridge, MA. As a key member of our Regulatory Affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key Responsibilities:Develop...
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Cambridge, Massachusetts, United States Takeda Full timeJob SummaryTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for device and combination product submissions.Key ResponsibilitiesDevelop and implement global regulatory strategies...
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Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
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Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
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Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
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Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
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