Associate Director, North America Regulatory Leader

Company: Disability Solutions
Location: Raritan
Posted on: February 15, 2025

Job Description:

Johnson and Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, North America Regulatory Leader in Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.\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.\rKey Responsibilities:

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• Key contributor to regulatory strategy plan, regulatory submission strategy, identifying submission risks, mitigations and opportunities, while leading regulatory applications and managing procedures through approvals.
• Develop, execute and oversee submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with US FDA and Health Canada Agency to find the best development strategies for novel therapies in the areas where no other precedents exist.
• Understand the regulatory framework, including regional trends, for various types of applications and provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities (US FDA, Health Canada) for assigned deliverable(s).
• Integrate inputs from regional and functional Global Regulatory Team members including input from external partnership for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in cardiovascular in different phases of development.
• Provide strategic regulatory input to key development documents, including clinical protocols, statistical analysis plan, clinical and nonclinical reports and summary documents.
• Drive the execution of regulatory plan for select health authority submissions and projects through close collaboration with multiple functional areas.
• In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective
• Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with NA regional teams, CMC, labeling, commercial strategies, and the Target Product Profile.
• Serve as a member of the Labeling Working Group, Clinical Teams, joint teams or joint Cross-Functional teams with external partner(s).
• Serve as primary point-of-contact to Health Authority
• Ensure compliance with internal and external policies and legislation
• Support or lead Due Diligence activities as appropriate
• Results and Performance Driven/Initiative: Assumes personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities.\r\r

Keywords: Disability Solutions, New Brunswick , Associate Director, North America Regulatory Leader, Executive , Raritan, New Jersey