Director, Global Regulatory Leader

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:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

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

Please 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):

US / Raritan, NJ or Titusville, NJ or Spring House, PA - Requisition Number: R-070493

Beerse, BE or Leiden, NL - Requisition Number: R-073285

High Wycombe, UK - Requisition Number: R-073289

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

We are searching for the best talent for Director, Global Regulatory Leader.

Purpose:

The Director, Global Regulatory Leader, is responsible for global regulatory strategies for select projects spanning the oncology therapeutic area.

You will be responsible for:

• Responsible for the development, implementation, and maintenance of robust Global regulatory strategies. Applies expert analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market.
• Lead the Global Regulatory Team and be a key contributor to multiple cross-functional teams such as Compound Development Team (CDT) to ensure timely commercialization of new and modified products into key markets.
• 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-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
• In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.
• Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. Achieves compliance with regulatory agency regulations by providing expert counsel to enable products that are developed, manufactured, or distributed to meet required legislation.
• Proactively creates a purpose driven environment by aligning Johnson & Johnsons Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
• Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.
• Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.
• Provide integrated global labeling and filing strategies for assigned projects.

Qualifications / Requirements:

Required Minimum Education:

• Minimum of a Bachelor’s degree in scientific discipline,
• Bachelor’s degree and 10+ years proven experience OR;
• Master’s degree/ PharmD and 7+ years of proven experience OR;
• PhD and 5+ years of proven experience.

Required Knowledge, Skills and Abilities:

• Experience leading interactions with Health Authorities is required. Global regulatory experience is required for the GRL role.
• Experience in drug development including early and/or late development, as well as a broad understanding of lifecycle management is required.
• Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
• Ability to work successfully as a leader and individual contributor is required.

Preferred Knowledge, Skills and Abilities:

• Previous experience in the oncology therapeutic area is highly preferred.
• Understanding of US and EMA labelling requirements for GRL role is preferred.
• In depth knowledge of current US FDA, Health Canada (and EMA for GRL) and global regulations as they relate to overall regulatory strategy is preferred.

This job posting is anticipated to close on May 11, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

#LI-Hybrid

 

 

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