Sr. Manager, Regulatory Program Management - Immunology

Senior Manager, Regulatory Program Management, Immunology Location: Multiple sites – U.S. (Cambridge, MA; La Jolla, CA; Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ) and international (Beerse, BE; Leiden, NL; Cork, IE; High Wycombe, UK; Allschwil, CH). Overview The Regulatory Program Manager (RPM) is a senior operational leader who translates global regulatory strategy into executable plans, coordinating cross‑functional teams to accelerate the delivery of the Johnson & Johnson Innovative Medicine portfolio. The role supports the most complex programs, mentors junior staff, and drives continuous improvement in regulatory processes. Responsibilities Empower teams to deliver the highest possible impact for programs, business, and patients worldwide. Translate regulatory requirements and strategy into executable plans, proactively identifying and mitigating risks. Lead operations with the Global Regulatory Team (GRT) to manage worldwide submissions, filing and launch sequencing, and pre‑ and post‑submission activities. Provide operational leadership and visualization support to enable rapid, informed decision‑making. Support and facilitate GRT, Submission Working Group, and Rapid Response Team meetings. Coordinate critical regulatory information and team communications for timely and accurate dissemination. Lead the operational execution of select marketing applications, including clinical variations and Pediatric submissions. Drive process improvements and embed best practices across programs and functions. Act as operational owner of the Global Filing and Launch Strategy. Establish processes and innovative methods to improve overall delivery. Refine RPM value proposition by prioritizing high‑impact activities and enabling enhanced capabilities. Mentor and coach other RPMs and team members. Work with budgeting and forecasting tools to maintain regulatory components and health authority budgets in Planisware. Support activity, resource, and cost planning across the R&D project portfolio. Travel up to 10% domestic and international as required. Qualifications Bachelor’s degree in Life Sciences, Business Management, Regulatory Affairs, or a related discipline (advanced degree preferred). Minimum 7 years of industry/business experience, with at least 3 years in a pharmaceutical, MedTech, or comparable R&D area. Experience in strategic planning, development of regulatory strategy, and managing global regulatory submissions (e.g., NDA, MAA, lifecycle documents). Project management experience leading global regulatory teams in a matrix setting. Experience leading submission teams and working with external partners. Demonstrated ability in business process, scenario, and critical path analysis on complex, accelerated projects. Knowledge of global regulations with in‑depth focus on FDA/EMA procedures. Understanding of Global Regulatory Affairs processes. Proficiency in project management standards, planning, and visualization methods/tools. Project management certification preferred; regulatory certification (RAC) preferred. Proficiency with Microsoft Project highly preferred. Excellent verbal and written communication, 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. Benefits Salary range: $122,000.00 – $212,750.00. Vacation: 120 hours per calendar year. Sick time: 40 hours per calendar year (48 in Colorado, 56 in Washington). Holiday pay including floating holidays: 13 days per calendar year. Work, Personal and Family Time: up to 40 hours per calendar year. Parental Leave: 480 hours within one year of birth/adoption/foster care. Bereavement Leave: 240 hours for an immediate family member, 40 hours for an extended family member per calendar year. Caregiver Leave: 80 hours in a 52‑week rolling period. Volunteer Leave: 32 hours per calendar year. Military Spouse Time‑Off: 80 hours per calendar year. Eligible for company retirement plan (pension), 401(k) savings plan, long‑term incentive program. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status. The company is committed to providing an inclusive interview process and will accommodate applicants with disabilities upon request. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine