Director, AI-Driven Regulatory Product Strategy

• Collaborate with the IM R&D Business and J&J Technology partners to develop, refine, and execute a technology vision and strategy that aligns with the overall program objectives.
• Understand and leverage emerging generative AI technologies to support submission acceleration and regulatory strategy.
• Design and implement AI technologies that streamline regulatory document workflows and health authority query response generation.
• Lead the creation of AI-ready data packages for downstream tools and applications.
• Support the adoption of new technologies among global regulatory teams to drive productivity.
• Lead the design, engineering, and operationalization of advanced AI products and solutions, ensuring scalable and seamless integration across the organization.
• Collaborate with Enterprise AI Technology Teams to drive capability requirements, governance alignment, system maturity and benchmarking.
• Establish and maintain strong relationships with internal and external stakeholders, including external vendors & partners.
• Implement and evolve AI governance practices and policies, ensuring compliance with regulatory and ethical standards.
• Prepare executive-ready status, dashboards, investment cases, CARs, and leadership presentations; ensuring clear storytelling of value, risks, and decisions.
• Co-Lead the decision-making process for AI architecture, platform selection, and build/buy/blend strategies in collaboration with the business leaders.
• Support the development and implementation of responsible AI practices, ensuring data privacy, model explainability, fairness, and ethical use of AI technologies.
• Mentor and lead multidisciplinary AI and technology product teams, fostering a culture of innovation, agility, and continuous improvement.

Requirements A minimum of a Bachelor's degree in a scientific, technical, or Information Technology related field is required. 10+ years in technical product development roles, with 3-5+ years of experience leading technical product teams. Strong understanding of global regulatory submission processes (e.g., FDA, EMA, PMDA) and compliance requirements. Deep understanding of R&D business objectives, industry domain, and the transformative potential of AI for R&D business models, workflows, and operations. Proven expertise in AI-driven technology transformation, including decision intelligence, agentic AI, and other transformative approaches. Comprehensive knowledge of regulatory and compliance frameworks relevant to AI and data protection. Demonstrated ability to build, lead, and motivate high-performing teams in dynamic, multidisciplinary environments. Ability to define the process and tracking TCO of the AI solutions and services. ATS Optimization Keywords Below are skills and terms extracted directly from this job posting to improve Applicant Tracking System (ATS) visibility. This unique feature helps candidates tailor their applications more effectively — a feature exclusive to JobTailor job listings. Hard Skills AI technologies regulatory document workflows data privacy model explainability decision intelligence agentic AI AI architecture AI governance practices technical product development TCO tracking Soft Skills collaboration leadership mentoring storytelling relationship building innovation agility continuous improvement team motivation communication #J-18808-Ljbffr Jobtailor