Director, Regulatory Policy - North America

Johnson & Johnson Innovative Medicine • Washington, DC

3d • Hybrid

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 https://www.jnj.com Job Function: Communications & Corporate/External Affairs Job Sub Function: Government Affairs & Policy 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 Director, Regulatory Policy - North America. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy - North America, is a strategic leader who responsible for shaping and advancing the company’s regulatory policy agenda across global and regional platforms. This role will drive proactive engagement with health authorities, trade associations, and internal stakeholders to influence regulatory frameworks that support innovation, patient access, and business objectives. This individual will bring deep expertise in regulatory systems, policy development, and external advocacy, with a proven ability to lead cross-functional initiatives in a dynamic biotechnology environment.

Requirements

• A minimum of a Bachelor’s degree in Regulatory Affairs, Public Policy, Law, Life Science, or a related discipline.
• A minimum of 10 years of experience in regulatory policy, government affairs, or regulatory strategy within the biotechnology or pharmaceutical industry is required.
• Experience engaging with major health authorities (e.g., FDA, Health Canada) is required.
• Demonstrated experience in influencing regulatory environments and shaping policy outcomes is required.
• Strong understanding of global regulatory systems is required.
• Strong knowledge of healthcare policy landscapes is required.
• Must have excellent oral and written communication skills.
• Must have strong negotiation and stakeholder management skills.
• The ability to lead cross-functional initiatives and influence decision-making in a matrixed organization.

Nice To Haves

• An advanced degree (Master’s, PharmD, Ph.D., J.D.) in Regulatory Affairs, Public Policy, Law, Life Sciences, or a related discipline is preferred.
• Experience previously working at major health authorities (e.g., FDA, Health Canada) is preferred
• Experience with digital health and/or artificial intelligence (AI) is preferred.
• Familiarity with regulatory frameworks for emerging technologies (e.g., cell and gene therapy, digital health, AI in medicine) is preferred.
• Global policy experience is preferred.

Responsibilities

• Regulatory Insights: Lead the assessment and synthesis of U.S. regulatory intelligence, identifying emerging trends, legislative changes, and strategic opportunities. Ensure targeted dissemination of insights to internal stakeholders, enhancing regulatory strategy and decision-making. Translate complex regulatory developments into actionable guidance for regional and global teams.
• Regulatory Policy Development: Develop and drive effective approaches to U.S. regulatory policy initiatives, with a specific focus on digital health in pharmaceutical drug development and/or Artificial Intelligence. Actively participate in regulatory commenting system, driving aligned internal perspectives, and coordinating company responses to draft regulations and guidance. Collaborate cross-functionally to develop and implement influencing strategies that shape the future healthcare environment. Provide strategic input to global working groups and policy platforms, integrating regional perspectives.
• External Representation and Advocacy: Represent the company in regional and global trade associations, professional organizations, and regulatory policy forums. Engage directly with health authorities and government bodies to advocate for science-based, innovation-friendly regulatory policies. Build and maintain trusted relationships with external stakeholders to advance the company’s policy positions.
• Strategic Engagement and Leadership: Serve as a visible and credible regulatory policy leader both internally and externally. Partner with Legal, Government Affairs, R&D, and Commercial teams to ensure policy alignment and strategic integration. Mentor and guide junior policy staff, fostering a culture of regulatory excellence and proactive engagement.

Benefits

• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees