Senior Manager, North America Regulatory Liaison

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. 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. Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities. Provide strategic regulatory input into key development documents (e.g., 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., 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. Identify and drive process improvements, applying critical thinking and problem-solving skills. Demonstrate strategic thinking, including contingency planning aligned with business objectives. Build and leverage strategic relationships and networks. A minimum of a Bachelor's degree in a scientific or technical discipline is required. 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.
Experience in pharmaceutical, biotech, or OTC industry is required. Strong knowledge of clinical drug development and regulatory pathways is required. Demonstrated experience preparing, reviewing, and delivering regulatory documentation is required. Experience in people management/coaching/mentoring is preferred. Must have the ability to exercise independent judgment in resolving complex regulatory and organizational challenges. The ability to effectively prioritize assignments for multiple products and projects simultaneously is required. This position may require up to 10% travel. 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. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. 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 Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Complian