Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations

1 month ago

Cambridge, United States Takeda Full time

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

  • Leadership in for the development and implementation of innovative pure device and combination product regulatory strategies particularly pertaining to the development, registration, commercialization and life cycle management with a focus on Material Sciences (including biocompatibility, extractables and leachables, material attributes, etc.), ensuring that 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, with emphasis on Material Sciences, and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
  • Globally influences and serves as a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry on Material Sciences
  • Influences changing regulations and guidance documents; and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy of 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


ACCOUNTABILITIES:

  • Responsible for demonstrating Takeda leadership behaviors
  • Acts as Foundational Subject Matter Expert/Platform Lead within Takeda on the topic of global regulation pertaining Material Sciences for devices and combination products
  • Provides tactical regulatory guidance on Material Sciences to product teams in line with global regulatory strategies
  • Develops strategies, tools and trainings to develop the combination product regulatory team on Material Sciences
  • Authors, reviews, provides critical assessments and gives input on 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
  • Reviews and approves 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 identifies combination product and device-related regulatory risks, ensuring timely communication with line management
  • Supports and/ or leads assigned device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
  • Provides global 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, 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.
  • Develops and maintains constructive relations with key internal and external stakeholders.
  • Develops CMC Device & Combination product staff on the subject of Material Sciences


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, 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


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

    2 months ago

    Cambridge, United States Takeda Full time

    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:...

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

    4 weeks ago

    Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionAt 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.Key...

  • Technical Regulatory Advisor, Drug-Device Combinations

    2 months ago

    Cambridge, United States Takeda Full time

    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:...

  • Regulatory Advisor for Drug-Device Combinations

    4 weeks 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...

  • Associate Director, Combination Product

    2 weeks ago

    Cambridge, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

  • Senior Manufacturing Engineer Medical Devices

    1 month ago

    Cambridge, Massachusetts, United States Care Dynamics, LLC Full time

    Job DescriptionAt Care Dynamics, LLC, we are seeking a highly skilled Senior Manufacturing Engineer to join our team in Cambridge, MA. This role will play a critical part in collaborating with R&D, Pilot, and commercial manufacturing teams to bring innovative medical devices from concept to commercialization.Key Responsibilities:Develop and optimize...

  • Senior Manufacturing Engineer

    1 month ago

    Cambridge, Massachusetts, United States Enterprise EQ Full time

    About the JobEnterprise EQ is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our medical device manufacturing team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key Responsibilities:Develop and optimize manufacturing...

  • Regulatory Affairs Director

    1 month ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...

  • Senior Manufacturing Engineer

    1 month ago

    Cambridge, Massachusetts, United States KLM Careers Full time

    Job DescriptionThe Senior Manufacturing Engineer will play a key role in the development and commercialization of new medical devices. This individual will collaborate closely with R&D, Pilot, and commercial manufacturing teams to ensure design and manufacturing processes are robust, scalable, and compliant with regulatory requirements.Key...

  • Medical Device Senior Manufacturing Engineer_CUS

    4 months ago

    Cambridge, United States Nexus Staff Inc. Full time

    Job Title: Medical Device Senior Manufacturing Engineer Employment Type: Contract Work Site: 100% Onsite Work Hours: 35 hrs./week Location: Cambridge, MA, United States Job Overview: The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new...

  • Medical Device Senior Manufacturing Engineer_CUS

    3 weeks ago

    Cambridge, United States Nexus Staff Inc. Full time

    Job Title: Medical Device Senior Manufacturing Engineer Employment Type: Contract Work Site: 100% Onsite Work Hours: 35 hrs./week Location: Cambridge, MA, United States Job Overview: The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new...

  • Medical Device Manufacturing Innovation Lead

    4 weeks ago

    Cambridge, Massachusetts, United States JM Chandler Dream Builders Full time

    About Canon USA's Boston Incubation CenterAt Canon USA's Boston Incubation Center, we're pushing the boundaries of medical research to create innovative, life-changing products. We're collaborating with world-class hospitals in the Boston area to turn cutting-edge ideas into reality.We're seeking an experienced Medical Device Manufacturing Innovation Lead to...

  • Medical Device Senior Manufacturing Engineer

    1 month ago

    Cambridge, United States KLM Careers Full time

    Medical Device Senior Manufacturing Engineer Cambridge MA Must be a US Citizen or Green Card holder. This is a 6 month contract NO C2C. The hiring manager is specifically seeking candidates with handson experience in cart systems console operations and electromechanical devices. When sourcing candidates please prioritize those who have demonstrated...

  • Medical Device Senior Manufacturing Engineer

    4 weeks ago

    Cambridge, United States KLM Careers Full time

    Medical Device Senior Manufacturing Engineer Cambridge MA Must be a US Citizen or Green Card holder. This is a 6 month contract NO C2C. The hiring manager is specifically seeking candidates with handson experience in cart systems console operations and electromechanical devices. When sourcing candidates please prioritize those who have demonstrated...

  • Medical Device Manufacturing Engineer

    4 weeks ago

    Cambridge, Massachusetts, United States KLM Careers Full time

    About the JobThe Senior Manufacturing Engineer will play a critical role in fostering collaboration between R&D, Pilot, and commercial manufacturing phases to contribute from Early Human Use to the commercialization of new medical products.This position will ensure that design and manufacturing processes are characterized, robust, scalable, and compliant...

  • Senior Director, Global Regulatory Lead, GI

    4 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    About the RoleWe are seeking a highly skilled Senior Director, Global Regulatory Lead, GI to join our team at Takeda. As a key member of our organization, you will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Key...

  • Director of Regulatory Affairs and Quality Assurance

    3 weeks ago

    Cambridge, United States Crescent City Recruitment Group Full time

    Director of Regulatory Affairs & Quality Assurance (RA/QA) We're working closely with the C-suite at an exciting medical-device company to recruit a Director of Regulatory Affairs & Quality Assurance, who will lead the development and execution of comprehensive regulatory and quality systems. This role is pivotal in both securing immediate FDA 510(k)...

  • Medical Device Senior Manufacturing Engineer

    4 weeks ago

    Cambridge, Massachusetts, United States KLM Careers Full time

    About the JobThe Senior Manufacturing Engineer will play a critical role in fostering collaboration between R&D, Pilot, and commercial manufacturing phases to contribute from Early Human Use to the commercialization of new medical products. This position will ensure that design and manufacturing processes are characterized, robust, scalable, and compliant...

  • Principal Combination Product Quality Engineer

    1 month ago

    Cambridge, Massachusetts, United States Alnylam Full time

    Job Title: Principal Combination Product Quality EngineerThis role is considered a hybrid position, combining technical and leadership responsibilities.Job Summary:The Principal Combination Product Quality Engineer will provide quality assurance support to Combination Product Design and Development, Design Transfer, and on-market support. This role will work...

  • Sr. CRA

    5 days ago

    Cambridge, United States ICON Strategic Solutions Full time

    Requires 5+ years of experienceEUMDR is preferred The Clinical Research Associate (CRA) - will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements....