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 for Immunology projects, with a strong focus on managing lifecycle submissions and interactions with Health Authorities. Proven ability to lead cross-functional teams and influence decision-making in a matrixed environment.

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 PreparationRegulatory Documentation ReviewRisk Identification and MitigationSubmission Timeline DevelopmentHealth Authority Approval Management

Soft Skills

Excellent CommunicationInterpersonal SkillsIndependent JudgmentLeadership CapabilitiesCollaboration Across Levels

Industry Keywords

Pharmaceutical IndustryBiotech IndustryOTC IndustryINDNDACTAMAA

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
Lead end-to-end planning, coordination, and execution of assigned deliverables
Contribute to regulatory submission strategies, identifying risks, mitigation plans, and opportunities
Provide regulatory input into clinical protocols, study reports, and summaries
Lead planning, preparation, and delivery of regulatory submissions across the product lifecycle
Develop and maintain submission 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 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 strategic thinking and contingency planning aligned with business objectives
Influence decision-making across a matrixed organization
Represent the company with Health Authorities and industry partners
Build and leverage strategic relationships and networks
May 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; or 4 years with a Ph.D.
Experience in pharmaceutical, biotech, or OTC industry is required
Strong knowledge of clinical drug development and regulatory pathways
Experience managing lifecycle submissions, such as 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 across all levels and influence decision-making within a cross-functional organization
Up to 10% travel may be required

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; Colorado employees – 48 hours; Washington employees – 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
Hybrid work arrangement
Up to 10 days of caregiver leave
Inclusive interview process and disability accommodations