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

2 days ago

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

We 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 Sciences.

Key Responsibilities:

  • Develop and implement regulatory strategies for device and combination products, 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 regulatory strategies, including technology transfer protocols, design verification and validation protocols, and technical reports.
  • Lead regulatory strategy, briefing book authoring, and meetings with global health authorities, including FDA, EMA, and Notified Bodies.
  • Review and approve medical device development design control documentation, ensuring alignment with regulatory requirements and standards.
  • Proactively identify regulatory risks and ensure timely communication with line management.
  • Support and/or lead assigned device-related aspects of global regulatory submissions, including Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, and Notified Body Opinions.
  • Provide global regulatory input and support on product-compliance related activities, including change controls, deviations, and investigations.
  • Work effectively across a complex matrix environment 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.
  • Experience working on cross-functional teams, 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.
  • 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, 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, including a 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.

  • 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 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...

  • Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations

    1 week ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job 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...

  • Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations

    2 days ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryTakeda is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. 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 drug-device...

  • Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations

    4 days ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. 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 drug-device combinations.Key...

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

    2 weeks ago

    Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionTakeda is seeking a highly skilled Senior Director and Regulatory Platform Lead to join our team in Cambridge, MA. As a key member of our Global Regulatory Affairs CMC Device and Drug-Device Combinations team, you will be responsible for end-to-end management of device and drug-device combination work outsourced to external partners.Key...

  • Senior Director and Regulatory Platform Lead for Device and Combination Products

    2 days ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job 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...

  • Senior Director and Regulatory Platform Lead for Device and Combination Products

    1 week ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job 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...

  • Senior Director and Regulatory Platform Lead for Device and Combination Products

    1 week ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job 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...

  • Regulatory Advisor for Drug-Device Combinations

    4 days ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job Title: Technical Regulatory Advisor, Drug-Device CombinationsTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are seeking a highly skilled Technical Regulatory Advisor to join our team and contribute to the development and implementation of innovative device and...

  • Regulatory Advisor for Drug-Device Combinations

    1 day ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryWe are seeking a highly skilled Regulatory Advisor to join our team at Takeda. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for drug-device combinations in the US market.Key ResponsibilitiesDevelop and implement regulatory strategies for drug-device combinations in...

  • Regulatory Affairs Director, Medical Devices, Molecular Testing and Biomarkers

    4 weeks ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our medical devices, molecular testing, and biomarkers regulatory strategy and oversight. As a key member of our team, you will be responsible for ensuring that our products meet the highest regulatory standards and are compliant with global regulations.Key...

  • Regulatory Affairs Director

    6 days ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    About the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....

  • Regulatory Strategy Director

    3 weeks ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Senior Director, Regulatory StrategyProclinical Staffing is seeking a seasoned professional to lead the development and execution of regulatory strategies for a global biotech company. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and mRNA platform technology.Key Responsibilities:The Senior...

  • Senior Manufacturing Engineer

    3 weeks ago

    Cambridge, Massachusetts, United States Enterprise EQ Full time

    About the RoleAs a Senior Manufacturing Engineer at Enterprise EQ, you will play a critical role in developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices. Your expertise will focus on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.Key...

  • Senior Manufacturing Engineer

    1 week ago

    Cambridge, Massachusetts, United States Intellectt Inc Full time

    Job Title: Senior Manufacturing Engineer – Medical DevicesWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Intellectt Inc. in Cambridge, MA. As a key member of our cross-functional team, you will play a critical role in ensuring the development and commercialization of new medical device products.Key...

  • Senior Principal Combination Product Quality Engineer

    1 week ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job Title: Senior Principal Combination Product Quality EngineerBiogen is seeking a seasoned Senior Principal Combination Product Quality Engineer to serve as an Associate Director within our Quality, Combination Products, and Devices team.Key Responsibilities:Provide comprehensive quality oversight for the lifecycle management of combination products.Lead...

  • Senior Manager, CMC Regulatory Expert

    1 week ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.Your RoleDevelop and execute CMC global submission plans and...

  • Senior Manager, CMC Regulatory Expert

    2 weeks ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...

  • Regulatory Advisor for Combination Products

    1 week ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryWe are seeking a highly skilled Regulatory Advisor to join our team at Takeda. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for combination products in the US market.Key ResponsibilitiesDevelop and implement regulatory strategies for combination products in the US...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Cambridge, Massachusetts, United States Takeda Full time

    About the RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device...