Associate Director, North America Regulatory Leader

Job Overview Associate Director, North America Regulatory Leader – responsible for defining and executing U.S. regulatory strategies for Immunology programs across the product lifecycle. Hybrid role based in Spring House, PA; remote work options may be considered on a case‑by‑case basis. Key Responsibilities Develop, refine, and implement comprehensive North American regulatory strategies aligned with global product objectives. Anticipate regulatory risks and opportunities and develop contingency plans to support program continuity. Provide strategic regulatory input into product development plans, study design, risk-benefit assessments, and lifecycle management activities. Lead and facilitate North American regulatory contributions across cross-functional teams, including Clinical, Labeling, CMC, Safety, and Submission Teams, and serve as a core member of the Global Regulatory Team. Work with the Global Regulatory Team to define global submission strategies and timelines, ensuring regional considerations are integrated early. Build strong working relationships with internal stakeholders and North American commercial operating companies to support product strategy and execution. Serve as the primary regulatory contact with North American Health Authorities and/or operating companies. Define the timing, strategy, and content for all North American Health Authority interactions within the context of the global regulatory strategy. Prepare company teams for Health Authority meetings and lead or participate in regulatory interactions as appropriate. Negotiate and manage post-approval commitments and ongoing regulatory obligations. Provide regulatory leadership for IND submissions and amendments, defining submission scope, content, and timing. Review and approve regulatory submissions prior to dispatch to Health Authorities. Lead development of clear, data-driven responses to FDA and other Health Authority inquiries, ensuring timeliness and consistency. Manage lifecycle submissions, including safety reports and post-approval changes. Contribute to the development and maintenance of Company Core Data Sheet (CCDS) and U.S. Prescribing Information (USPI). Support labeling strategy development, prepare documentation, and lead or support labeling negotiations with Health Authorities. Review adverse experience safety reporting and ensure alignment with regulatory requirements. Review labeling content to ensure claims are supported by appropriate documentation and data. Demonstrate strong interpersonal and leadership skills, fostering collaboration across matrixed teams. Support effective resource planning and deliver high-quality results in a fast‑paced, multi‑product environment. 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; 6 years with a master’s or PharmD; or 4 years with a Ph.D. is required. Solid understanding of the drug development lifecycle, from discovery and clinical development through commercialization. Working knowledge of FDA and ICH regulatory requirements, including clinical research, product development, and labeling. Demonstrated understanding of Health Authority organization structures and review processes (preferred). Knowledge of the Immunology therapeutic area preferred. Excellent oral and written communication skills. Strong organization and multi-tasking skills. Ability to effectively prioritize assignments for multiple products and projects simultaneously. Ability to operate effectively as a strategic contributor and decision maker within a global, cross‑functional organization. Requires up to 10% domestic and international travel. Compensation US salary ranges: $137,000–$235,750 in the U.S.; $157,000–$271,400 in the San Francisco Bay Area, CA. Eligible for an annual performance bonus and long‑term incentive program. Remuneration and Benefits Overview We offer comprehensive medical, dental, vision, life, disability, and retirement benefits, along with vacation and sick time. For a full benefits list, please visit the company's benefits page. Equal Opportunity Employer 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 veterans and individuals with disabilities. If you have a disability and would like an accommodation, please contact the company’s accommodation resource. For more information, visit the company's contact page. #J-18808-Ljbffr