Senior Analyst, Regulatory Program Management – Immunology

Johnson & Johnson

. Facilitate assigned service areas within the Regulatory Program Management department and ensure visibility to the book of work .

Posted 11/3/2026full-timeUnited StatesSenior💰 $112,000 - $180,550 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory program management, project management, and strategic planning within the pharmaceutical or MedTech industries. Capable of leading cross-functional teams, driving process improvements, and translating regulatory strategies into actionable plans.

Highest-signal resume keywords

Regulatory Strategy DevelopmentProject Management ExperienceCross-Functional Team LeadershipRisk Mitigation and Opportunity EvaluationVeeva Platform Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements TranslationBusiness Process AnalysisScenario AnalysisCritical Path AnalysisOperational ExecutionSubmission PlanningProcess ImprovementHealth Authority Meeting PreparationGlobal Filing StrategyDecision-Making Support

Soft Skills

Excellent Communication SkillsInnovative ThinkingStrategic ThinkingInfluencing Without AuthorityTeam Decision-Making

Tools & Technologies

PlaniswareMicrosoft Project ServerReporting ToolsVisualization ToolsProject Management Standards

Certifications & Qualifications

Project Management CertificationProcess Excellence Certification

Industry Keywords

PharmaceuticalMedTechRegulatory Program ManagementR&DGlobal Regulatory ProcessesClinical VariationsPediatric SubmissionsHealth Authority BudgetsGlobal RegulationsCross-Functional Management

About the role

Key responsibilities & impact

Facilitate assigned service areas within the Regulatory Program Management department and ensure visibility to the book of work
Monitor quality and processes to support RPM department success
Lead change management and implementation for new processes and systems across the RPM team
Lead Global Regulatory Team operations, including health authority meeting planning, worldwide submissions, global filing and launch strategy, regulatory strategy consolidation, pre- and post-submission activities, and health authority meeting preparation
Translate regulatory requirements and strategy into executable plans
Identify and mitigate risks and evaluate opportunities for acceleration
Provide operational leadership, scenario and visualization support, and decision-making support to Regulatory and program teams
Facilitate Global Regulatory Team, Submission Working Group, Rapid Response Team, and similar meetings
Coordinate regulatory information and team communications, including with co-development and external partners
Lead operational execution of select marketing applications, clinical variations, and Pediatric submissions
Develop submission plans, define team roles and accountabilities, and mitigate risks
Drive process improvements and embed best practices across programs, therapeutic areas, and functions
Establish processes, procedures, and innovative methods across organizational boundaries
Refine RPM delivery and lead efforts to enhance capabilities and impact
Build and maintain regulatory components and health authority budgets in Planisware
Support activity, resource, and cost planning across the R&D project portfolio

Requirements

What you’ll need

Minimum of a Bachelor’s degree is required
Minimum of 4 years of industry/business experience with at least 2 years of experience in a Pharmaceutical, MedTech or comparable R&D area
Project management experience leading cross-functional teams in a matrix setting
High proficiency 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 to 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
Candidates must already have authorization to work in the country of employment
Immigration sponsorship and relocation support are not available
Candidates authorized to work pursuant to a short-term status who require future immigration sponsorship are not eligible
Preferred: experience in strategic planning and development of global regulatory strategy and cross-functional management of global regulatory processes
Preferred: experience working with clinical and/or regulatory teams in the early development space
Preferred: knowledge of global regulations, guidelines and regulatory requirements
Preferred: proficiency in the Veeva platform
Preferred: high proficiency with Microsoft Project Server and/or online environment
Preferred: high proficiency in reporting tools and report development
Preferred: project management and/or process excellence certification

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick 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 year
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/foster care of a child
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and disability accommodations
Up to 10% domestic and international travel