Johnson & Johnson Innovative Medicine
Director, Regulatory Policy - North America
Johnson & Johnson Innovative Medicine, Washington, District of Columbia, us, 20022
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.
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.
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
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, Life Science, or a related discipline is required. An advanced degree (Master’s, PharmD, Ph.D., J.D.) is preferred.
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.
Experience working at a major health authority 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.
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.
This position will require minimal travel.
Compensation The anticipated base pay range for this position in U.S. locations is $150,000 to $258,750. The company maintains highly competitive, performance‑based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Employees and/or eligible dependents may be eligible to participate in the 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)).
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year (up to 56 hours per calendar year for employees residing in Washington, D.C.)
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Required Skills
Advocacy Communications
Budget Management
Compliance Management
Corporate Communications Strategy
Corporate Management
Cross Sector Collaboration
Government Relations
Leverages Information
Negotiation
Public Affairs
Public Policies
Regulatory Development
Relationship Building
Representing
Stakeholder Engagement
Tactical Planning
Technical Credibility
Preferred Skills
Advocacy Communications
Budget Management
Compliance Management
Corporate Communications Strategy
Corporate Management
Cross Sector Collaboration
Government Relations
Leverages Information
Negotiation
Public Affairs
Public Policies
Regulatory Development
Relationship Building
Representing
Stakeholder Engagement
Tactical Planning
Technical Credibility
Application Deadline This job posting is anticipated to close on January 27, 2026. The Company may however extend this time‑period; in that case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Equal Opportunity Employer Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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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.
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
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, Life Science, or a related discipline is required. An advanced degree (Master’s, PharmD, Ph.D., J.D.) is preferred.
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.
Experience working at a major health authority 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.
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.
This position will require minimal travel.
Compensation The anticipated base pay range for this position in U.S. locations is $150,000 to $258,750. The company maintains highly competitive, performance‑based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Employees and/or eligible dependents may be eligible to participate in the 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)).
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year (up to 56 hours per calendar year for employees residing in Washington, D.C.)
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Required Skills
Advocacy Communications
Budget Management
Compliance Management
Corporate Communications Strategy
Corporate Management
Cross Sector Collaboration
Government Relations
Leverages Information
Negotiation
Public Affairs
Public Policies
Regulatory Development
Relationship Building
Representing
Stakeholder Engagement
Tactical Planning
Technical Credibility
Preferred Skills
Advocacy Communications
Budget Management
Compliance Management
Corporate Communications Strategy
Corporate Management
Cross Sector Collaboration
Government Relations
Leverages Information
Negotiation
Public Affairs
Public Policies
Regulatory Development
Relationship Building
Representing
Stakeholder Engagement
Tactical Planning
Technical Credibility
Application Deadline This job posting is anticipated to close on January 27, 2026. The Company may however extend this time‑period; in that case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Equal Opportunity Employer Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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