Senior Director, Global Regulatory Leader, CAR-T Therapy

4 weken geleden

Rotterdam, Zuid-Holland, Nederland J&J Family of Companies Voltijd

Senior Director, Global Regulatory Leader, CAR-T Therapy W

Description

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. This position can be located either in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, England.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

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. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. 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.

Key Responsibilities:

  • 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)
  • Ensure, facilitate and/or lead the development or enhancement of constructive relationships and associations with Health Authorities and thought leaders in appropriate business critical settings.
  • Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
  • Lead the preparation and participate in meetings with FDA, EMA, PMDA, CDE, Health Canada and other Health Authorities (HAs) as required.
  • 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.
  • Support or lead Due Diligence activities as appropriate.

Qualifications

Qualifications

Education:

  • Minimum of a B.S. in a life sciences or technical discipline is required
  • An advanced degree in the biological sciences is preferred (e.g., M.S., Ph.D., M.D.)

Experience and Skills:

Required:

  • A minimum of 15 years in drug development any of the following areas (e.g. 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
  • Experience establishing productive working relationships with Health Authorities and gaining a deep understanding of how regulators view certain drug development issues is required
  • Experience leading a matrixed global team of diverse individuals is required

Preferred:

  • Strong preference for candidates successfully working on advanced therapies (gene and cell therapies)
  • Strong preference for candidates successfully working on both early and late development programs.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. 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.

The anticipated base pay range for this position in the US is $187,000 to $322,000.

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

Primary Location NA-US-New Jersey-Raritan

Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-US-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Affairs

Req ID: W


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