Sr. Manager, Regulatory Program Management - Immunology

At 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 jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Project/Program Management GroupJob Sub Function: Project/Program ManagementJob Category:ProfessionalAll Job Posting Locations:Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of AmericaJob Description:About ImmunologyOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Cambridge, MA; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Allschwil, Switzerland; or Cork, Ireland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):Spring House, PA or Horsham, PA or Titusville, NJ or Raritan, NJ or Cambridge, MA or La Jolla, CA - Requisition Number: R-075620Beerse, BE or Leiden, NL or Cork, IE - Requisition Number: R-076539High Wycombe, UK- Requisition Number: R-076543Allschwil, CH - Requisition Number: R-076545Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.We are searching for the best talent for Senior Manager, Regulatory Program Management, Immunology.Purpose:The Regulatory Program Manager (RPM) will be an asset-level operational leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of cross-functional team efforts. The RPM will serve as the primary project management point of contact to ensure Regulatory functional plans are aligned with compound/program objectives and commitments. RPMs will work closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the delivery of the Johnson & Johnson Innovative Medicine (JJIM) portfolio. The RPM is guided in all matters by the Johnson & Johnson Credo and held to Johnson & Johnson Leadership Performance Standards.This RPM role is part of the Immunology Delivery Unit and aligned with JJIM’s organizational and portfolio support structure.The Sr. Manager, RPM, will be deployed in support of JJIM’s most complex programs, called on to lead critical department initiatives and may represent the function with organizational leadership and in larger capability enhancement efforts at cross-functional and organizational levels. This individual will be expected to provide coaching, education and mentoring to more junior staff and select team efforts, while driving continuous enhancement of RPM impact for the organization.Principal Responsibilities:Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation, and business case development).Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of worldwide submissions, driving processes to optimize global filing and launch sequencing, pre and post-submission activities, preparation for health authority meetings and additional major regulatory milestones.Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation.Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Liaise with Compound Development Team (CDT) and Senior Leadership Team (SLT) partners to prepare discussions and drive meeting outcomes.Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed submission plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.Drive process improvements and embed best practices from across programs, TAs, and functions into supported teams.Act as operational owner of the Global Filing and Launch Strategy.Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.Serve as a mentor and coach to other RPMs and team members. As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.Support and facilitate activity, resource, and cost planning across the R&D project portfolio, as required.Qualifications:A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline. Advanced degree preferred. A minimum of 7 years’ experience of industry/business is required.A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required.Experience in strategic planning and development of regulatory strategy, and cross-functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) across various phases of the drug development cycle is required.Project management experience leading global regulatory teams in a matrix setting is required.Experience leading submission teams and working with external partners is preferred.Demonstrated experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines required.Knowledge of global regulations, guidelines, and regulatory requirements with in-depth knowledge/focus of FDA/EMA procedures is required.Demonstrated understanding of Global Regulatory Affairs processes is required.Proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.Project management certification preferred.Regulatory certification (RAC) preferred.Proficiency with Microsoft Project is highly preferred.Must have excellent verbal and written communication skills.Must have strong innovative and strategic thinking skills.The ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.The ability to resolve controversy and influence teams without formal authority is required.The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.This position will require up to 10% domestic and international travel.This job posting is anticipated to close on May 22, 2026. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.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, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.#LI-HybridRequired Skills:Preferred Skills:Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross-Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical CredibilityThe anticipated base pay range for this position is :$122,000.00 - $212,750.00Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raritan, New Jersey, United States of America; Horsham, Pennsylvania, United States of America; Cambridge, Massachusetts, United States of America; Titusville, New Jersey, United States of America; Spring House, Pennsylvania, United States of America; San Diego, California, United States of AmericaType: Full time