Director, Global Regulatory Leader

Johnson & Johnson

Director, Global Regulatory Leader responsible for developing regulatory strategies in innovative medicine. Overseeing global collaboration and compliance for advanced cell therapy and rare disease products.

Posted 5/14/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $164,000 - $282,900 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

A minimum of a Bachelor’s degree is required, preferably in a scientific or technical discipline
Advanced degree (Master’s, PharmD or PhD) 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

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
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

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Hard Skills & Tools

regulatory strategy developmentregulatory compliancesubmission document reviewclinical trial designlabelingrisk managementadvanced therapiesdrug product lifecycleglobal regulatory experienceFDA and ICH guidelines

Soft Skills

leadershipcommunication skillsorganizational skillsmulti-taskingcollaborationrelationship buildingindependent judgmentproblem-solvingstrategic thinkingprioritization

Certifications

Bachelor’s degreeMaster’s degreePharmDPhD