Senior Director, Head of Regulatory Intelligence

Johnson & Johnson Innovative MedicineNew Brunswick, NJ
9d$178,000 - $307,050

About The Position

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. Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, define and implement a multi-year strategic roadmap for regulatory intelligence, and oversee the integration of proactive regulatory insights into organizational decision-making. Our vision is to transform proactive regulatory intelligence into a strategic competitive advantage by anticipating the GxP risk landscape, safeguarding product quality and patient safety, and enabling the compliant growth and supply of J&J's medicines and medical devices. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and translating complex regulatory signals into proactive, actionable insights that drive better business outcomes. The ideal candidate understands that regulatory intelligence only creates value when it is actionable, governed, and decision focused and brings the skills and experience needed to bring this vision to reality. The ideal candidate is an inspiring people leader who is passionate about growing talent, building organizational capability, and influencing stakeholders across all levels of the enterprise.

Requirements

  • Previous industry experience in building and leading a proactive regulatory intelligence organization within a complex, global organization.
  • Demonstrated success in setting and executing a strategic roadmap for regulatory intelligence, translating vision into measurable outcomes.
  • Proven ability to synthesize high volumes of regulatory signals into prioritized, decision-ready insights and experience building governance frameworks that ensure the right signals are acted on and mitigated.
  • Deep expertise in Good Manufacturing Practices (GMP) for pharmaceuticals, biologics, CAR-T, and medical devices.
  • Strong understanding of global health authorities' regulations and enforcement practices.
  • Demonstrated ability to develop and execute strategic initiatives at the executive level.
  • Exceptional synthesis, storytelling, and business translation skills. Strong ability to convert complex regulatory data into compelling narratives and strategic recommendations for executive audiences.
  • Strong persuasion and influencing capabilities with a track record of driving alignment and shaping decisions across diverse, matrixed stakeholder groups.
  • Proven leadership skills with experience in building high-performing teams and fostering collaboration across a matrixed organization.

Nice To Haves

  • Previous experience with developing platforms for regulatory intelligence (e.g. AI-driven analytics) is highly preferred.
  • Previous experience as a compliance leader (e.g. U.S. FDA, Office of Compliance) or inspector at a global health authority (e.g., U.S. FDA, MHRA, etc.) is preferred but not required.

Responsibilities

  • Set strategic direction and priorities for the Proactive Regulatory Intelligence team to ensure alignment with organizational goals with a focus on proactively identifying and communicating regulatory risks and opportunities.
  • Define, own, and drive execution of a comprehensive strategic roadmap for regulatory intelligence ensuring the function evolves in alignment with the broader organizational strategy.
  • Leverage strong persuasion and influencing skills to drive alignment and adoption of proactive regulatory intelligence priorities across senior leadership and key stakeholders.
  • Engage at the senior executive level to drive the adoption of proactive regulatory intelligence as a core input to organizational strategy and decision-making.
  • Partner with sector intelligence partners in Innovative Medicine and MedTech to anticipate regulatory developments before they impact the business.
  • Establish and govern a structured framework for regulatory signal management to ensure every signal is assessed, prioritized, and resolved with a documented decision creating organizational clarity and accountability.
  • Prepare concise, actionable executive briefings on anticipated and emerging GxP regulations, health authority enforcement, and industry trends translating regulatory complexity into clear business implications and recommended actions.
  • Lead a high-performing team, fostering a culture of innovation, collaboration, and continuous improvement.
  • Conduct advocacy for key enterprise-wide initiatives in close coordination with Innovative Medicine and MedTech sectors.
  • Build and maintain relationships with global health authorities and key external stakeholders to enable early awareness of evolving regulatory expectations.

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

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

No Education Listed

Number of Employees

5,001-10,000 employees

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