Director, Global 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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan New Jersey United States of America Spring House Pennsylvania United States of America Titusville New Jersey 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 & Johnson Innovative Medicine R&D is recruiting for a Director Global Regulatory Leader. This position is a hybrid role and can be located in Spring House PA; Titusville NJ; or Raritan NJ.

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 Director Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development implementation and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.

Principal Responsibilities:

• As the global regulatory lead for assigned projects develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area. Ensure strategies are aligned with portfolio objectives regional regulatory requirements CMC considerations commercial goals and market access plans.

• Serve as the key regulatory point of contact providing leadership and guidance across cross-functional teams to support successful development and commercialization including providing input on implications of regulatory strategy through participation in product-related teams.

• Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.

• Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs). Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.

• Lead and oversee key health authority documents (e.g. IND/CTA meeting requests briefing packages responses marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements.

• Negotiate and manage regional post-approval commitments and global label expansion strategies.

• Maintain an understanding of the competitive landscape (e.g. views of HAs regulatory precedents labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.

• Maintain working knowledge of laws guidances and requirements related to autoimmune diseases in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs labeling risk management and development programs to meet global and regional requirements.

• Support due diligence and business development assessments.

• Identify and resolve regulatory issues that may affect projects or organizational objectives.

Qualifications:

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

• A minimum of 10 years of global health regulated industry is required.

• Global regulatory experience with deep expertise in U.S. FDA EMA and international regulations within scientific and commercial contexts is required.

• Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.

• An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research product development and labeling is required.

• An understanding of the regulatory submission and approval process is required.

• Experience critically reviewing and compiling regulatory documents is required.

• Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred.

• Knowledge of advanced therapies such as CAR-T is strongly preferred.

• Demonstrated ability to interpret and apply regulatory requirements and precedents is required.

• A proven track record in shaping global regulatory strategies ensuring compliance and leading direct interactions with Health Authorities is required.

• Must have excellent oral and written communication skills.

• Must have strong organization and multi-tasking skills.

• A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred.

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

• The ability to exercise independent judgment and execution in anticipating evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions 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 $189000 to $325450.

The anticipated base pay range for this position in U.S. locations is $164000 to $282900.

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.

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 Companys 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

For additional general information on company benefits please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on December 16 2025. 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.

#LI-Hybrid

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

The anticipated base pay range for this position in the San Francisco Bay Area CA is $189000 to $325450. The anticipated base pay range for this position in U.S. locations is $164000 to $282900.

Additional Description for Pay Transparency:

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 Additional information can be found through the link below. Experience:

Director