Director, Global Regulatory Leader (GRL) - Raritan New Jersey

Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 02/03/2025

Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ.\rAt 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 https://www.jnj.com/. \rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rThe Director, Global Regulatory Leader, is responsible for global regulatory strategies for select projects spanning the oncology therapeutic area. The role also offers North American Regulatory Leader responsibilities for a select oncology project.\rEssential functions:

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• Responsible for the development, implementation, and maintenance of robust Global / North American/ regulatory strategies.
• Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).
• 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.
• Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
• In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.
• Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards.\r\rIn GRL role leading the Global Regulatory Team (GRT):\r
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  • Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.
  • Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.
  • Provide integrated global labeling and filing strategies for assigned projects\r\rIn NARL role:
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    • Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.
    • Serve as primary point of contact for US FDA
    • Lead the regulatory response team for FDA and Health Canada questions.
    • Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities
    • Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.\r\r More...

          

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