Sr. Manager, Regulatory Program Management - Immunology in High Wycombe

The Senior Manager, Regulatory Program Management, Immunology leads operational project management for Johnson & Johnson’s innovative medicines, translating global regulatory strategy into actionable plans and coordinating cross‑functional teams to deliver high‑quality submissions.

Purpose

The Regulatory Program Manager (RPM) is an operational leader who drives projects forward, translating global regulatory strategy into executable plans and coordinating cross‑functional teams to ensure confidence, quality, and speed in delivering the JJIM portfolio.

Principal Responsibilities

• Empower teams to deliver the highest impact for programs, business, and patients worldwide.
• Translate regulatory requirements and strategy into detailed executable plans, identify risks, and capitalize on acceleration opportunities.
• Lead operations with Global Regulatory Team to manage worldwide submissions, optimize filing and launch sequencing, and coordinate pre‑ and post‑submission activities.
• Provide operational leadership to Regulatory and program teams, driving rapid, informed decision‑making and fostering innovation.
• Facilitate GRT, Submission Working Group, and Rapid Response Team meetings to maintain a high‑performance culture.
• Ensure coordination of critical regulatory information and communications to stakeholders.
• Lead execution of marketing applications, including clinical variations and pediatric submissions, aligning strategies and mitigating risks.
• Drive process improvements and embed best practices across programs.
• Own Global Filing and Launch Strategy operations.
• Collaborate across functions to establish processes and innovative methods that improve delivery.
• Refine RPM value proposition to prioritize high‑impact areas.
• Mentor and coach other RPMs and team members.
• Support budgeting, forecasting, and cost planning using Planisware.
• Facilitate activity, resource, and cost planning across the R&D project portfolio.

Qualifications

• Bachelor’s degree in Life Sciences, Business Management, Regulatory Affairs, or related discipline; advanced degree preferred.
• Minimum 7 years of industry/business experience.
• Minimum 3 years in Pharmaceutical, MedTech, or comparable R&D area.
• Experience in strategic planning and development of regulatory strategy, and cross‑functional management of global regulatory submissions and processes across phases of drug development.
• Project management experience leading global regulatory teams in a matrix setting.
• Preferred experience leading submission teams and working with external partners.
• Experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines.
• In-depth knowledge of FDA and EMA procedures and global regulations.
• Proficiency in global regulatory affairs processes.
• Proficiency in project management standards, planning, and visualization tools.
• Project management certification preferred.
• Regulatory certification (RAC) preferred.
• Proficiency with Microsoft Project highly preferred.
• Excellent verbal and written communication skills.
• Strong innovative and strategic thinking skills.
• Ability to drive and expedite team decision‑making and translate strategy into clear action plans.
• Ability to resolve controversy and influence teams without formal authority.
• Ability to influence decision‑making at all levels and represent project teams with senior leadership.
• Up to 10% domestic and international travel required.

Preferred Skills

• Agile Decision Making, agility, analytics insights, business alignment, continuous improvement, cross‑functional collaboration, leadership, organizational project management, program management, project management methodology, project management office, project reporting, statement of work, technical credibility.

This posting is anticipated to close on May 22, 2026.