Senior Manager, North America Regulatory Liaison

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

8d•$140,000 - $241,500•Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting a Senior Manager, North America Regulatory Liaison, based in Spring House, Pennsylvania; Titusville, New Jersey; or Raritan, New Jersey. This hybrid role serves as a strategic regulatory leader, driving North America regulatory strategy and execution for assigned Immunology projects. The position partners with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities. It balances risk mitigation with opportunity maximization to support successful Immunology product development and lifecycle management. The role leads end-to-end planning, coordination, and execution of assigned regulatory deliverables. It contributes to regulatory submission strategies; plans, prepares, and delivers submissions across the product lifecycle; manages applications and procedures through Health Authority approvals; and leads Health Authority interactions, including briefing materials and responses. The Senior Manager collaborates with global regulatory and cross-functional teams, provides stakeholder updates, drives process improvements, influences decisions in a matrixed organization, and may serve as Regional Regulatory Leader for assigned programs. Travel of up to 10% may be required.

Requirements

A minimum of a Bachelor’s degree in a scientific or technical discipline.
At least 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.
Experience in the pharmaceutical, biotech, or OTC industry.
Strong knowledge of clinical drug development and regulatory pathways.
Experience managing lifecycle submissions, such as IND, NDA, CTA, and MAA.
Demonstrated experience preparing, reviewing, and delivering regulatory documentation.
A proven track record interacting with the 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 effectively prioritize assignments for multiple products and projects simultaneously.
Ability to collaborate with all levels and influence decision-making within a cross-functional organization.

Nice To Haves

An advanced degree (Master’s, PharmD, or Ph.D.) in a scientific or technical discipline.
Experience in the Immunology therapeutic area.
Experience in people management, coaching, or mentoring.

Responsibilities

Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities.
Provide strategic regulatory input into development documents, including clinical protocols, study reports, and summaries.
Apply knowledge of regional and global regulatory frameworks, trends, and requirements across all phases of development.
Lead planning, preparation, and delivery of regulatory submissions, from simple to complex, across the product lifecycle.
Develop and maintain submission delivery timelines, content plans, and execution strategies.
Author and/or critically review submission components to ensure quality and compliance.
Manage regulatory applications and associated procedures through Health Authority approvals.
Serve as a primary point of contact with Health Authorities, such as the FDA.
Lead and coordinate Health Authority interactions, including preparation of briefing materials and responses.
Manage responses to regulatory queries and requests.
Partner with global regulatory and cross-functional teams to align submission and interaction plans.
Lead or contribute to cross-functional submission teams to ensure timely and effective execution.
Communicate clear, proactive status updates to stakeholders.
Identify and drive process improvements using critical thinking and problem-solving skills.
Apply strategic thinking, including contingency planning aligned with business objectives.
Influence decision-making across a matrixed organization.
Represent the company externally with Health Authorities and industry partners, as appropriate.
Build and leverage strategic relationships and networks.
May serve as Regional Regulatory Leader for assigned programs.

Benefits

Eligibility to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified higher amounts for eligible 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: 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.