Director, Regulatory Policy - North America

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:

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 will be 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.

Principal 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.

 

Qualifications:

• A minimum of a Bachelor’s degree in Regulatory Affairs, Public Policy, Law