Senior Analyst, Regulatory Program Management – Immunology

Johnson & Johnson•La Jolla, PA

15h

About The Position

The Senior Analyst, Regulatory Program Manager (RPM) is an operational leader who advances and optimizes services delivered by the RPM team. The role supports visibility into the team’s book of work, assesses processes, monitors quality, and leads change management and implementation for new processes and systems. When assigned to programs, the Senior Analyst translates global regulatory strategy into executable plans and coordinates cross-functional efforts. Working closely with the Global Regulatory Leader and partners in Regulatory Affairs, Project Management, Medical Writing, Clinical, and other functions, the role aligns regulatory plans with compound and program objectives and commitments across the Innovative Medicine Immunology portfolio. The Senior Analyst supports regulatory and compound project teams while also strengthening critical business processes within the RPM department. The role may lead Global Regulatory Team operations, support worldwide submissions and health authority meeting planning, coordinate marketing applications, and facilitate teams’ planning, decision-making, risk management, and communications. The position may also support budgeting, forecasting, and activity, resource, and cost planning across the R&D project portfolio. The position may be based in Spring House or Horsham, Pennsylvania; Titusville or Raritan, New Jersey; Cambridge, Massachusetts; La Jolla, California; Beerse, Belgium; Leiden, Netherlands; Maidenhead, United Kingdom; Basel, Switzerland; or Cork, Ireland. Candidates must already be authorized to work in the country of employment. Immigration sponsorship and relocation support are not available. The role requires up to 10% domestic and international travel.

Requirements

Bachelor’s degree required; an advanced degree is preferred.
At least 4 years of industry or business experience, including at least 2 years in a Pharmaceutical, MedTech, or comparable R&D area.
Project management experience leading cross-functional teams in a matrix environment.
High proficiency in and demonstrated application of project management standards, planning, and visualization tools.
Demonstrated experience conducting business process, scenario, and critical path analysis.
Ability to drive and expedite team decision-making and translate strategy into clear, executable action plans.
Excellent verbal and written communication skills.
Strong innovative and strategic thinking skills.
Ability to resolve controversy and influence teams without formal authority.
Willingness and ability to travel up to 10% domestically and internationally.
Must already be authorized to work in the country of employment; immigration sponsorship and relocation support are unavailable, and candidates on short-term status who will require future sponsorship are ineligible.

Nice To Haves

Experience in strategic planning and development of global regulatory strategy and cross-functional management of global regulatory processes.
Experience working with clinical and/or regulatory teams in early development.
Knowledge of global regulations, guidelines, and regulatory requirements.
Proficiency in the Veeva platform.
High proficiency with Microsoft Project Server and/or its online environment.
High proficiency in reporting tools and experience developing reports.
Project management and/or process excellence certification.
Advanced degree.

Responsibilities

Facilitate assigned RPM service areas, ensuring visibility into the book of work and monitoring processes and quality.
Lead change management and implementation for new processes and systems across the RPM team.
Where assigned, lead Global Regulatory Team operations, including visibility into or management of health authority meeting planning, worldwide submissions, global filing and launch strategy processes, and key early- and late-development deliverables.
Translate regulatory requirements and strategy into executable plans that clarify priorities, identify and mitigate risks, and pursue opportunities for acceleration, using tools such as project plans, risk and opportunity playbooks, scenario evaluation, and business cases.
Provide operational leadership to Regulatory and program teams, using scenarios and visualizations to support rapid, informed decision-making and encourage innovation.
Support a high-performance Global Regulatory Team culture by facilitating GRT, Submission Working Group, Rapid Response Team, and similar meetings as needed.
Coordinate regulatory information and team communications so the GRT strategy and operational status are disseminated accurately and promptly, including to co-development and other external partners as required.
Lead operational execution of selected marketing applications, including clinical variations and Pediatric submissions; align regulatory and compound submission strategies, develop detailed plans, clarify roles and accountabilities, and help teams mitigate risks and pursue opportunities.
Drive process improvements and incorporate best practices from programs, therapeutic areas, and functions into supported teams.
Work across functions and organizational boundaries to establish processes, procedures, and innovative methods that improve delivery.
Continuously refine RPM delivery, prioritize high-impact opportunities, and lead efforts to enhance the team’s capabilities and impact.
As required, use standard budgeting, forecasting, and reporting tools to build and maintain regulatory components and health authority budgets in Planisware as part of a coordinated project plan.
As required, support and facilitate activity, resource, and cost planning across the R&D project portfolio.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year; different amounts apply for employees residing in Colorado or 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 the birth, adoption, or foster care of a child.
Bereavement leave: up to 240 hours for an immediate family member and 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.