Director, North America Regulatory Affairs Leader

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: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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 We are searching for the best talent for a Director, North America Regulatory Affairs Leader based in Raritan, NJ, Titusville, NJ, or Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: The Director, North America Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies. This role develops and executes robust global and North American regulatory strategies, leads the NA Regulatory Team, and provides strategic direction across cross-functional development teams. The leader ensures NA alignment across portfolio priorities; oversees and critically reviews key regulatory submissions; and leads and supports interactions with FDA. The role also ensures regulatory compliance, supports due diligence, and advances drug development strategies that address global and regional market needs. You will be responsible for: Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements. Serve as primary point of contact for US FDA Lead the regulatory response team for FDA and Health Canada questions. Ensure US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues. Manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct. Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback. Establishes major aspects of functional Regulatory Affairs initiatives by taking into account corporate strategies and compliance regulations to drive innovation and ensure timely commercialization of new and modified products into key markets. Controls regulatory compliant plans by collaborating with internal stakeholders including Research & Development (R&D), Marketing, and other leaders to create cross-functional policies for driving the optimum portfolio of innovative products. Recommends solutions for product development strategies based on anticipated regulatory changes and emerging issues to prevent potential regulatory challenges Partners with internal stakeholders to influence regulatory policies and positions to drive convergence between future regulatory policy and functional plans. Communicates existing policies and changes in the regulatory environment to management and assists in developing solutions for known issues to implement improvements within the organization. Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs. Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise. Education: Minimum of a Bachelor’s degree in scientific or equivalent discipline is required Advanced Degree is preferred (MS, PhD, PharmD) Required: Minimum of 10 years of relevant experience. Experience leading interactions with Health Authorities. US regulatory experience. Broad understanding and experience in drug development, including early and late development, as well as a broad understanding of lifecycle management. Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment. Working knowledge of US labeling requirements, and EMA labeling requirements. In depth knowledge of current US FDA, Health Canada (and EMA for GRL) and global regulations as they relate to overall regulatory strategy. Experience managing a portfolio of multiple products. Ability to work successfully in a matrixed environment as a leader and individual contributor. People and project management skills, strong oral & written communication skills and organization & multi-tasking skills. Exercises independent judgment and execution in anticipating, interpreting, evaluating and resolving complex organization issues with novel solutions. Encourages and embraces input from broad range of stakeholders to capture diverse perspectives. Identifies and enhances business/work processes to embed an environment of innovation to remain competitive. Preferred: Previous experience in Oncology, cell therapies, or other complex modalities Johnson & Johnson is an Equal Opportunity Employer. A