Senior Manager, North America Regulatory Liaison

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Through our expertise in Innovative Medicine and Med Tech, 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.

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Regulatory Affairs Group

Regulatory Affairs

Professional

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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.

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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;
Titusville, NJ; or Raritan, NJ.

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Represent the company externally with Health Authorities and industry…