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 note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-027513

• Canada - Requisition Number: R-032876

• United Kingdom - Requisition Number: R-032879

• Belgium Netherlands - Requisition Number: R-032880

• Switzerland - Requisition Number: R-032883

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

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

The Director Global Regulatory Leader will be responsible for the development implementation and maintenance of robust global regulatory strategies for select projects spanning the same target disease areas.

Principal Responsibilities:

• Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams.

• Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs meeting requests briefing documents response documents and marketing and supplemental applications.

• Ensure that regulatory strategies are aligned with product portfolio regional strategies CMC (Chemistry Manufacturing and Controls)-Regulatory Affairs strategy commercial and market access strategy and the Target Product Profile (for global programs as assigned).

• In interacting with the Health Authorities lead and/or participate in meetings with FDA Health Canada EMEA and other Health Authorities (HAs) as appropriate.

• Develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.

• Ensure business compliance and implementation of and adherence to regulatory standards.

• Serve as a member of Labeling Working Group (LWG) to create or update the Company Core Data Sheet (CCDS) and contribute to the development of local labels as appropriate. Provide regulatory input to clinical development programs risk/benefit assessments medical affairs programs and for the target label.

• Provide integrated global labeling and filing strategy for assigned projects

Qualifications:

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

• A minimum of 10 years of overall regulatory experience with a Bachelors degree; a minimum of 7 years of overall regulatory experience with a Masters or PharmD degree; or a minimum of 5 years of overall regulatory experience with a Ph.D. is required.

• Global regulatory experience is required.

• Experience leading interactions with Health Authorities is required.

• A broad understanding and experience in drug development including early and late development is required.

• A broad understanding of lifecycle management is required.

• In depth knowledge of current U.S. FDA EMEA Health Canada and global regulations as they relate to the overall regulatory strategy is required.

• Working knowledge of U.S. and/or global labeling requirements is preferred.

• Experience in the Neuroscience therapeutic area is preferred.

• Experience managing a portfolio of multiple products is preferred.

• Project management skills required.

• Must have excellent oral and written communication skills.

• Must have strong organizational time management and multi-tasking skills.

• Must have effective critical thinking and problem-solving skills.

• The ability to exercise independent judgment and execution in anticipating evaluating and resolving complex functional and/or complex organizational issues with novel solutions is required.

• The ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.

• The ability to collaborate successfully in a matrixed environment as a leader and individual contributor is required.

• This position will require up to 10% travel.

The anticipated base pay range for this position in U.S. locations is $160000 to $276000.

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 September 24 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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

The anticipated base pay range for this position in U.S. locations is $160000 to $276000.

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:

Exec