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    Lead Director - England, United Kingdom - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson England, United Kingdom

    3 weeks ago

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    Description
    Job Description - Senior Director, Global Regulatory Leader, CAR-T Therapy W)
    Senior Director, Global Regulatory Leader, CAR-T Therapy W

    Johnson & Johnson is currently seeking a Senior Director, Global Regulatory Leader for transformational chimeric antigen receptor T (CAR-T) cell products within the Oncology Therapeutic Area portfolio.

    Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular, metabolic, and retinal diseases.

    Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. It's a culture that celebrates diversity and diverse perspectives.

    It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

    The Senior Director, Global Regulatory Leader, CAR-T Therapy will be responsible for the development, implementation and maintenance of global regulatory strategies for transformational therapies in the Oncology portfolio.

    Bring innovative regulatory approaches, deeply rooted in science to lead the team in discussion with global health authorities to find the best development strategies for novel therapies in the area.

    Be responsible for the development, implementation and maintenance of robust global regulatory strategies for transformational therapies targeted to address unmet needs in Oncology in different phases of development.

    Drive the execution of the regulatory strategies for select projects through close collaboration with functional areas and ensure the regulatory strategies are aligned with the overall Therapeutic Area strategy, regional strategies, CMC-RA strategy, and commercial strategy.

    Lead the Global Regulatory Team (GRT) and contribute effectively on multiple cross-functional teams including but not limited to the Compound Development Team, Global Dossier Team, Clinical Team, and the Labeling Working Group.

    Ensure that regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands)

    Serve as a member of LWG to create or update the CCDS and contributes to the development of local labels as appropriate.

    Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
    Drive innovative regulatory strategies and advance regulatory knowledge sharing, identify process improvement opportunities for cell/gene therapies, and facilitate policy shaping as the GRA Oncology point of contact for cell/gene therapy regulatory policy
    Lead a Cell/Gene Therapy Community of Practice for GRA Oncology to leverage experiences and drive efficiencies for CAR-T/gene therapy products under development in the TA
    Ensure compliance with internal and external policies and legislation.
    Global Regulatory Affairs, R&D or health authority role) is required.
    ~10 years within the pharmaceutical/biotech industry is required, along with a minimum 5 years of recent regulatory affairs experience
    ~ A track record of innovative scientific thinking and application is required
    ~ Significant experience in the development and execution of global regulatory strategies, the drug development process, regulatory compliance, and regulatory strategy for product lifecycle management is required
    ~ Strong preference for candidates successfully working on advanced therapies (gene and cell therapies)

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

    All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.

    If you are an individual with a disability, please check ourpage for information on how to request an accommodation.
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