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 GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of AmericaJob Description:About Innovative MedicineOur 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 & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA.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:Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.Collaborate with cross-functional submission delivery teams.Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.Serve as primary point-of-contact to Health Authority.If necessary, this position may work as Regional Regulatory Leader.May represent Johnson & Johnson or company externally with limited supervision.May cultivate and leverage strategic networks and partnerships.Demonstrate the ability of strategic thinking and contingency planning with respect to corporate objectives.Demonstrate effective critical thinking, including problem solving and goal setting for improved efficiency.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 Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required.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.Knowledge of clinical drug development is required.Experience working with the U.S. FDA and global regulatory Health Authorities (HAs) is required.Experience responding to FDA and other HA requests and managing HA interactions is required.Experience in lifecycle management of IND/NDA/CTA/MAA and other regulatory submissions is required.Demonstrated experience in critically reviewing and compiling regulatory documents is required.Experience in the Neuroscience therapeutic area is preferred.Experience in people management/coaching/mentoring is preferred.Must have excellent communication and interpersonal skills.Must have strong organization and time management skills.Must have the ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions.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.The anticipated base pay range for this position in U.S. locations is $137,000 to $235,750.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:Vacation - 120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar yearHoliday pay, including Floating Holidays - 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave - 480 hours within one year of the birth/adoption/foster care of a childCondolence Leave - 30 days for an immediate family member: 5 days for an extended family memberCaregiver Leave - 10 daysVolunteer Leave - 4 daysMilitary Spouse Time-Off - 80 hoursFor additional general information on Company benefits, please go to: - This job posting is anticipated to close on May 22, 2026. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.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 , internal employees contact AskGS to be directed to your accommodation resource.#LI-HybridRequired 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 CredibilitySummaryLocation: Titusville, New Jersey, United States of America; Raritan, New Jersey, United States of America; Spring House, Pennsylvania, United States of AmericaType: Full time