Associate Director, North America Regulatory Leader

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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 & Johnson Innovative Medicine R&D is recruiting for an Associate Director North America Regulatory Leader. This position is a hybrid role and will be located in Spring House PA.

Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. While specific cities are listed in the Locations section for reference please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The Associate Director North America Regulatory Leader will be accountable for defining and executing U.S. regulatory strategies for Immunology programs across the product lifecycle. This role will provide regulatory leadership for assigned assets ensure alignment with global regulatory strategy and serve as the primary North American regulatory interface with the FDA and other applicable Health Authorities. This individual will partner closely with global and cross functional teams to enable timely development approval and lifecycle management of products.

Principal Responsibilities:

• Develop refine and implement comprehensive North American regulatory strategies aligned with global product objectives.

• Anticipate regulatory risks and opportunities and develop contingency plans to support program continuity and success.

• Provide strategic regulatory input into product development plans study design risk-benefit assessments and lifecycle management activities.

• Lead and facilitate North American regulatory contributions across crossfunctional teams including Clinical Labeling CMC Safety and Submission Teams and serves as a core member of the Global Regulatory Team (GRT).

• Work with the GRT to define global submission strategies and timelines ensuring regional considerations are integrated early and effectively.

• Build strong working relationships with internal stakeholders and North American commercial operating companies to support product strategy and execution.

• Serve as the primary regulatory contact with North American Health Authorities and/or Operating Companies.

• Define the timing strategy and content for all North American Health Authority interactions within the context of the global regulatory strategy.

• Prepare company teams for Health Authority meetings and lead or participate in regulatory interactions as appropriate.

• Negotiate and manage postapproval commitments and ongoing regulatory obligations.

• Provide regulatory leadership for IND submissions and amendments defining submission scope content and timing.

• Review and approve regulatory submissions prior to dispatch to Health Authorities.

• Lead development of clear datadriven responses to FDA and other Health Authority inquiries ensuring timeliness strategic alignment and consistency with regulatory commitments.

• Manage lifecycle submissions including safety reports and postapproval changes.

• Contribute to the development and maintenance of Company Core Data Sheet (CCDS) and U.S. Prescribing Information (USPI).

• Support labeling strategy development prepare supporting documentation and lead or support labeling negotiations with Health Authorities.

• Review Adverse Experience (AE) safety reporting and ensure alignment with regulatory requirements.

• Review labeling content to ensure claims are supported by appropriate documentation and data.

• Demonstrate strong interpersonal and leadership skills fostering collaboration across matrixed teams.

• Support effective resource planning and deliver highquality results in a fastpaced multiproduct environment.

Qualifications:

• A minimum of a Bachelors degree in a scientific or technical discipline is required. Advanced degree (Masters PharmD Ph.D.) in a scientific or technical discipline preferred.

• A minimum of 8 years of relevant regulatory experience with a Bachelors degree; a minimum of 6 years of relevant regulatory experience with a Masters or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.

• Solid understanding of the drug development lifecycle from discovery and clinical development through commercialization is required.

• Working knowledge of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements including clinical research product development and labeling is required.

• Demonstrated understanding of Health Authority organizational structures and review processes is preferred.

• Knowledge of the Immunology therapeutic area is preferred.

• Must have excellent oral and written communication skills.

• Must have strong organization and multi-tasking skills.

• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.

• The ability to operate effectively as both a strategic contributor and decision maker within a global crossfunctional organization is required.

• This position may require up to 10% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area CA is $157000 to $271400.

The anticipated base pay range for this position in U.S. locations is $137000 to $235750.

The Company maintains highly competitive performance-based compensation programs. 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 corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• Subject to the terms of their respective plans employees and/or eligible dependents are 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.

• Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys long-term incentive program.

• Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits:

• Vacation - 120 hours per calendar year

• Sick time - 40 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

• Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member

• Caregiver Leave - 10 days

• Volunteer Leave - 4 days

• Military Spouse Time-Off - 80 hours

• For additional general information on Company benefits please go to: - job posting is anticipated to close on June 9 2026. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

  
  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 internal employees contact AskGS to be directed to your accommodation resource.

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  Required Skills:

  Preferred Skills:

  Analytical Reasoning Business Writing Compliance Risk Fact-Based Decision Making Industry Analysis Legal Support Mentorship Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Strategic Thinking Tactical Planning Technical Credibility