Senior Manager, Regulatory Policy Research

Johnson & JohnsonColumbia, WA
Hybrid

About The Position

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.

Requirements

  • A minimum of a Bachelor’s degree in a scientific discipline (public health administration, regulatory affairs, public policy or related) is required.
  • 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.
  • 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.
  • Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Microsoft Teams) is required.
  • Must have excellent oral and written communication and facilitation skills.
  • Must have strong analytical skills.
  • Must have strong negotiation and stakeholder management skills.
  • The ability to translate complex scientific, regulatory, and policy information into clear insights, recommendations, and executive-ready deliverables is required.

Nice To Haves

  • Advanced degree (Master’s, PharmD, Ph.D.) in a scientific discipline is preferred.
  • 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.
  • 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.
  • Experience with technology-enabled process improvement, digital health, artificial intelligence, or emerging regulatory policy topics is preferred.

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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

Benefits

  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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