Senior Manager, North America Regulatory Liaison

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.  Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a  Senior Manager, North America Regulatory Liaison.  This position is a hybrid role and will be located in Spring House, PA.

The Senior Manager, North America Regulatory Liaison will serve as a strategic regulatory leader, driving North America regulatory strategy and execution for assigned Immunology projects.  This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities.  The position will require a strategic mindset, balancing risk mitigation with opportunity maximization to enable successful Immunology product development and lifecycle management.

The Senior Manager, North America Regulatory Liaison, will be responsible for leading the end-to-end planning, coordination and execution of assigned deliverables.

Principal Responsibilities:

Regulatory Strategy & Leadership:

• Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities.

• Provide strategic regulatory input into key development documents (e.g., clinical protocols, study reports, summaries).

• Apply knowledge of regional and global regulatory frameworks, trends, and requirements across all phases of development.

Submission Planning & Execution:

• Lead the planning, preparation, and delivery of regulatory submissions (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, ensuring quality and compliance.

• Manage regulatory applications and associated procedures through Health Authority approvals.

Health Authority Engagement:

• Serve as primary point of contact with Health Authorities (e.g., FDA).

• Lead and coordinate Health Authority interactions, including preparation of briefing materials and responses.

• Manage responses to regulatory queries and requests.

Cross-functional Collaboration:

• Partner with global regulatory and cross-functional teams to align on 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.

Operational Excellence & Influence:

• Identify and drive process improvements, applying critical thinking and problem-solving skills.

• Demonstrate strategic thinking, including contingency planning aligned with business objectives.

• Influence decision-making across a matrixed organization.

Representation & Networking:

• Represent the company externally with Health Authorities and industry partners, as appropriate.

• Build and leverage strategic relationships and networks.

Additional Scope:

• May serve as Regional Regulatory Leader for assigned programs.

Qualifications:

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required.  Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.

• A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; a minimum of 6 years of relevant regulatory experience with a Master’s or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.

• Experience in pharmaceutical, biotech, or OTC industry is required.

• Strong knowledge of clinical drug development and regulatory pathways is required.

• Experience managing lifecycle submissions (e.g., IND, NDA, CTA, MAA) is required.

• Demonstrated experience preparing, reviewing, and delivering regulatory documentation is required.

• Proven track record interacting with FDA and other global Health Authorities is required.

• Experience in Immunology therapeutic area preferred.

• Experience in people management/coaching/mentoring is preferred.

• Must have excellent communication and interpersonal skills.

• Must have strong stakeholder management skills.

• Must have the ability to exercise independent judgment in resolving complex regulatory and organizational challenges.

• Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.

• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.

• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

• This position may require up to 10% travel.

Johnson & Johnson is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.  We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.  If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility