Senior Manager, Regulatory Policy Research

Job description

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: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Washington, District of Columbia, 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 Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Regulatory Policy Research. This position is a hybrid role and can be located in Washington D.C. or Raritan, NJ. The Senior Manager, Regulatory Policy Research sits within the Policy Research and Operations (PRO) group, which will be responsible for shaping and scaling the tools, research approaches, regulatory intelligence resources, and operational processes that enable the Global Regulatory Policy and Intelligence (GRPI) team to anticipate policy developments, prioritize issues, and execute high-impact regulatory policy strategies. This role leads complex cross-functional work across GRPI and the broader GRA organization. This individual will perform analysis of emerging regulatory and scientific issues to identify actionable insights; develop, roll-out, and manage fit-for-purpose systems and processes that improve policy planning, commenting, advocacy, and external engagement. The Senior Manager is expected to operate with independence and minimal supervision, provide strategic recommendations to policy leaders, and work capably across the organization’s scientific, policy, operational, and technology domains. Principal Responsibilities: Strategic Research and Regulatory Intelligence Leadership Lead complex scientific, regulatory, and policy research to inform GRPI priorities, advocacy positions, strategic plans, and leadership decision-making. Translate emerging policy, regulatory, and scientific developments into clear implications, options, and recommendations for GRPI and GRA leaders. Establish research standards, improve intelligence processes, and mentor others on effective use of regulatory intelligence tools and sources. Regulatory Intelligence Strategy and Capability Building Shape regulatory intelligence approaches that help GRPI anticipate external developments, identify risks and opportunities, and support timely, evidence-based policy decisions. Lead training, adoption, and best-practice sharing for regulatory intelligence resources across GRPI and relevant GRA stakeholders. Research Synthesis and Executive Deliverables Develop high-quality documents, presentations, policy positions, and leadership materials that synthesize complex information into practical implications and recommend actions aligned with business, scientific, and regulatory priorities. Policy Tools, Systems, and Process Strategy Design, develop, and scale tools, processes, and technology-enabled approaches that strengthen GRPI priority-setting, policy planning, commenting, knowledge management, and performance tracking. Identify unmet business needs, define user requirements, recommend solutions, and drive implementation and adoption across GRPI and GRA. Partner with the PRO Director on strategic direction while independently leading execution of complex, high-visibility initiatives. Commenting Program Leadership Lead operational strategy and governance for GRPI-led commenting efforts on health authority documents and global regulatory initiatives. Ensure commenting processes are efficient, compliant, well-documented, and aligned with Johnson & Johnson policy positions. Facilitate cross-functional alignment, identify areas of policy sensitivity or inconsistency, support resolution of competing viewpoints, and ensure final outputs reflect clear, evidence-based company positions. Knowledge Management and Digital Enablement Lead development and continuous improvement of the GRPI website and related collaboration tools to ensure they provide effective support for policy planning, research, commenting activities, and knowledge sharing. Policy Strategy and External Engagement Enablement Partner with policy leads to shape and operationalize policy strategies for priority external engagements, including trade associations, consortia, workshops, and other policy forums. Provide strategic coordination across policy topics, identify cross-cutting themes, anticipate decision points, and ensure stakeholders have the insights, materials, and follow-up needed to advance Johnosn & Johnson objectives. Consultant and Resource Strategy Partner with the PRO Director to plan and manage external consultant support for GRPI priorities, including scopes of work, renewals, work allocation, deliverable quality, budget tracking, and vendor performance. Identify when external expertise is needed and ensure consultant resources are aligned to the highest-priority policy and intelligence needs. People Leadership In a non-supervisory capacity, provide day-to-day leadership, coaching, prioritization, and performance feedback for team members to support policy research, intelligence, operations, tools, and commenting activities. Set expectations, reviews work quality, supports capability develop Qualifications: A minimum of a Bachelor’s degree in a scientific discipline (public health administration, regulatory affairs, public policy or related) is required. Advanced degree (Master’s, PharmD, Ph.D.) in a scientific discipline is preferred. A minimum of 8 years in the pharmaceutical, biotechnology, medical device, public health, regulatory agency, or trade association environment is required. A minimum of 6 years of experience in Regulatory Affairs, regulatory policy, regulatory intelligence, public health policy or a related function is required. Solid understanding of the global regulatory environment, including U.S., European Union (EU), and Asia Pacific (AP) regions is preferred. Experience at a health authority, trade association, or policy-focused organization is preferred. Advanced project management skills, including experience leading complex cross-functional initiatives and projects in a global matrix environment, required. Experience working with stakeholders with varied areas of expertise is required. Demonstrated ability to translate regulatory, scientific, or policy information into strategic recommendations for senior stakeholders is required. Experience leading regulatory policy, intelligence, commenting, knowledge management, or external engagement initiatives is preferred. Experience providing work direction, coaching, feedback, and prioritization for direct reports, matrixed colleagues, or project team members is preferred. Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Microsoft Teams) is