Senior Manager, North America Regulatory Liaison

Johnson & Johnson

. Drive North America regulatory strategy and execution for assigned Immunology projects .

Posted 9/17/2026full-timeSpring House • New Jersey • United StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and execution within the Immunology field, with a strong focus on managing lifecycle submissions and interactions with Health Authorities. Proven ability to lead cross-functional teams, influence decision-making, and ensure compliance throughout the product lifecycle.

Highest-signal resume keywords

Regulatory Strategy DevelopmentLifecycle Submission ManagementFDA Interaction ExperienceClinical Drug Development KnowledgeStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationIND ManagementNDA ManagementCTA ManagementMAA ManagementRegulatory Documentation ReviewRisk Mitigation PlanningSubmission Timeline DevelopmentCritical ThinkingProblem-Solving

Soft Skills

Excellent CommunicationInterpersonal SkillsLeadership CapabilitiesCollaborationInfluencing Decision-Making

Industry Keywords

Pharmaceutical IndustryBiotech IndustryOTC IndustryImmunology Therapeutic AreaHealth Authority ComplianceRegulatory FrameworksCross-Functional CollaborationMatrixed Organization

About the role

Key responsibilities & impact

Drive North America regulatory strategy and execution for assigned Immunology projects
Partner with global and cross-functional leaders to shape development pathways and influence key decisions
Ensure high-quality, timely interactions with Health Authorities
Lead end-to-end planning, coordination, and execution of assigned deliverables
Contribute to regulatory submission strategies, identifying risks, mitigation plans, and opportunities
Provide strategic regulatory input into clinical protocols, study reports, and summaries
Apply regional and global regulatory frameworks, trends, and requirements across all development phases
Lead planning, preparation, and delivery of regulatory submissions across the product lifecycle
Develop and maintain submission delivery timelines, content plans, and execution strategies
Author and critically review submission components for quality and compliance
Manage regulatory applications and procedures through Health Authority approvals
Serve as primary point of contact with Health Authorities, including the FDA
Lead Health Authority interactions and prepare briefing materials and responses
Manage responses to regulatory queries and requests
Partner with global regulatory and cross-functional teams on submission and interaction plans
Lead or contribute to cross-functional submission teams
Communicate proactive status updates to stakeholders
Identify and drive process improvements
Apply critical thinking, problem-solving, strategic thinking, and contingency planning
Influence decision-making across a matrixed organization
Represent the company externally with Health Authorities and industry partners
Build and leverage strategic relationships and networks
Potentially serve as Regional Regulatory Leader for assigned programs

Requirements

What you’ll need

A minimum of a Bachelor’s degree in a scientific or technical discipline is required
A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; 6 years with a Master’s or PharmD degree; or 4 years with a Ph.D. is required
Experience in pharmaceutical, biotech, or OTC industry is required
Strong knowledge of clinical drug development and regulatory pathways
Experience managing lifecycle submissions, including IND, NDA, CTA, and MAA
Experience preparing, reviewing, and delivering regulatory documentation
Proven experience interacting with FDA and other global Health Authorities
Excellent communication and interpersonal skills
Strong stakeholder management skills
Ability to exercise independent judgment in resolving complex regulatory and organizational challenges
Strong leadership capabilities and ability to work successfully in a matrixed environment
Ability to prioritize assignments for multiple products and projects simultaneously
Ability to collaborate with all levels and influence decision-making within a cross-functional organization
Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred
Experience in Immunology therapeutic area preferred
Experience in people management/coaching/mentoring preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; employees residing in Colorado – 48 hours; employees residing in Washington – 56 hours
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Up to 10% travel
Inclusive interview process and disability accommodations