Senior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI

The S enior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI, will lead the strategic implementation of the URP globally. By leveraging a close partnership with Information Technology (JJIT), this role will drive product management excellence while contributing to the broader strategy of the Regulatory Operations and Digital Innovation (RODI) organization. A key member of the RODI Senior Leadership Team, this role is critical to modernizing regulatory processes, achieving business outcomes, and delivering faster access to medicines for patients worldwide. The Senior Director, URP will be pivotal in positioning Global Regulatory Affairs (GRA) as a forward-thinking, industry-leading strategic partner, driving critical business outcomes and accelerating access to medicines for patients globally. This role will modernize regulatory processes, ensuring they remain adaptable and effective in the ever-evolving regulatory landscape. The ideal candidate will have a strong background in regulatory affairs, technology, and process optimization, as well as experience leading large-scale transformation initiatives. As a transformational leader, the Senior Director will champion a culture of agility, fostering innovation through digital tools and new ways of working, while maintaining a strong focus on creating positive user experiences and driving increased operational efficiency across the organization. Additionally, this role will ensure the program is anchored in business outcomes, while delivering critical capabilities enabled by technology and digital innovation. Responsibilities:

• Develop, articulate, and shape the overall vision, strategy, and key results (OKRs) for the URP program, aligning them with broader business goals. Partner with senior stakeholders to define long-term success metrics and ensure continuous alignment between business strategy and technology implementation.
• Develop and lead the strategic roadmap for the URP program, aligning the initiative with organizational goals and objectives and our future state technology blueprint.
• Set priorities, shape the product backlog, and guide the translation of requirements into user stories and acceptance criteria, leveraging business expertise and a deep understanding of customer needs.
• Define and track meaningful metrics throughout the product lifecycle to ensure business value realization, including monitoring end user KPIs and product performance.
• Act as a change champion, driving cultural and operational shifts across teams, and ensuring cross-functional alignment in support of the transformation.
• Function as an influential decision-maker in cross-functional collaboration, prioritization, and resolution of roadblocks to drive alignment and progress across teams.
• Drive necessary changes to business processes, adoption strategies, and other elements to maximize the value derived from the products and solutions delivered.
• Serve as the "voice of the customer" and ensure that the teams are building the right products and solutions that meet stated business needs and achieve desired outcomes.
• Collaborate closely with key stakeholders, clarifying requirements and delivery expectations, and ensuring successful product launches and continuous improvement efforts across the URP product lifecycle.
• Build and manage a high-performing URP team dedicated to supporting the transformation initiative and ongoing operations.
  
  Bachelor's degree in scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field.
• 10+ years overall work experience.
• 8 years in pharmaceutical or healthcare industry.
• People or team management experience across a matrix organization.
• Excellent analytical skills with diligence and effective communication at all levels.
• Demonstrated ability to translate data into information, and strategies into actionable plans.
• Experience leading strategic product initiatives and managing complex projects.
• Strong business and technical acumen, with the ability to bridge regulatory and IT teams
• Fosters a culture of support and collaboration.
• Commitment to Our Credo, Diversity, Equity & Inclusion (who we are and what we believe) by ensuring we are attracting, developing and retaining talent that reflect the communities our teams serve.
• Focuses on business agility, agile delivery with a fail-fast mindset, and measurable outcomes.
• Strong leader, collaborator, and individual contributo r.
• Strong problem-solving skills with a focus on innovation and continuous improvement.
• Develop and maintain trusting relationships to provide feedback to the internal team to help guide thinking and facilitate issue resolution.
• Experience working in a global, matrixed organization.
• Demonstrated ability to lead cross-functional teams and manage complex projects.
• Proven ability to lead, mentor, and develop diverse global teams in a matrixed environment, fostering collaboration and innovation.
• Strong organizational and time-management skills.
  
  J&J Family of Companies Senior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI in High Wycombe, United Kingdom
Senior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI
• Job titleSenior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI
• FunctionRegulatory Affairs Group
• Sub functionRegulatory Product Submissions and Registration
• CategorySenior Director, Regulatory Product Submissions and Registration (PL10)